Apparatus and method to asynchronously fill and purge channels of endoscope simultaneously

ABSTRACT

A method is provided for reprocessing an internal channel of a medical device with a reprocessing system having a valve, a fluid line fluidly coupled with the valve, and at least one sensor coupled with the fluid line. The method includes performing an actuation of the valve to direct liquid through the fluid line and into the internal channel, and detecting with the at least one sensor a predetermined condition within the fluid line while the liquid is being directed into the internal channel. In response to detecting the predetermined condition, a time duration measured from the actuation of the valve is recorded. The method further includes purging the liquid from the internal channel, and directing liquid through the fluid line and into the internal channel for the time duration.

This application is a divisional of U.S. patent application Ser. No.16/117,010, entitled “Apparatus and Method to Asynchronously Fill andPurge Channels of Endoscope Simultaneously,” filed Aug. 30, 2018, thedisclosure of which is incorporated by reference herein, which is acontinuation-in-part of U.S. patent application Ser. No. 15/704,276,entitled “Apparatus and Method to Repeatedly Fill and Purge Channels ofEndoscope,” filed Sep. 14, 2017, now patented as U.S. Pat. No.10,792,386, issued Oct. 6, 2020, the disclosure of which is incorporatedby reference herein.

BACKGROUND

The below discussion relates to the reprocessing (i.e., decontamination)of endoscopes and other instruments that are used in medical procedures.In particular, the below discussion relates to an apparatus and a methodthat may be used to reprocess a medical device such as an endoscopeafter the medical device has been used in a first medical procedure,such that the medical device may be safely used in a subsequent medicalprocedure. While the below discussion will speak mainly in terms of anendoscope, it should be understood that the discussion may also equallyapply to certain other medical devices.

An endoscope may have one or more working channels or lumens extendingalong at least a portion of the length of the endoscope. Such channelsmay be configured to provide a pathway for passage of other medicaldevices, etc., into an anatomical region within a patient. Thesechannels may be difficult to clean and/or disinfect using certainprimitive cleaning and/or disinfecting techniques. Thus, the endoscopemay be placed in a reprocessing system that is particularly configuredto clean endoscopes, including the channels within endoscopes. Such anendoscope reprocessing system may wash and disinfect the endoscope. Suchan endoscope reprocessing system may include a basin that is configuredto receive the endoscope, with a pump that flows cleaning fluids overthe exterior of the endoscope within the basin. The system may alsoinclude ports that couple with the working channels of the endoscope andassociated pumps that flow cleaning fluids through the working channelsof the endoscope. The process executed by such a dedicated endoscopereprocessing system may include a detergent washing cycle, followed by arinsing cycle, followed by a sterilization or disinfection cycle,followed by another rinsing cycle. The sterilization or disinfectioncycle may employ disinfectant solution and water rinses. The finalrinsing cycle concludes with purging the endoscope channels withcompressed air. Optionally, the process may further include an alcoholrinsing cycle in which the endoscope channels are filled with alcoholand then purged with compressed air to facilitate drying of the channelsand thereby enhancing the decontamination effects of the process.

Examples of systems and methods that may be used to reprocess a usedendoscope are described in U.S. Pat. No. 6,986,736, entitled “AutomatedEndoscope Reprocessor Connection with Integrity Testing,” issued Jan.17, 2006, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 7,479,257, entitled “Automated Endoscope ReprocessorSolution Testing,” issued Jan. 20, 2009, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 7,686,761, entitled“Method of Detecting Proper Connection of an Endoscope to an EndoscopeReprocessor,” issued Mar. 30, 2010, the disclosure of which isincorporated by reference herein; and U.S. Pat. No. 8,246,909, entitled“Automated Endoscope Reprocessor Germicide Concentration MonitoringSystem and Method,” issued Aug. 21, 2012, the disclosure of which isincorporated by reference herein. An example of a commercially availableendoscope reprocessing system is the EVOTECH® Endoscope Cleaner andReprocessor (ECR) by Advanced Sterilization Products of Irvine, Calif.

Some versions of reprocessing systems may provide just a single use of acertain volume of disinfectant solution, such that the used volume ofdisinfectant solution is disposed of after a single use of the volume ofdisinfectant solution upon completion of the disinfection cycle. Someother versions of reprocessing systems may provide multiple uses of thesame volume of disinfectant solution. Specifically, a volume ofdisinfectant solution may be recovered upon completion of a disinfectioncycle and then reused for one or more subsequent disinfection cycles. Insome applications, for both single-use disinfectant systems andmulti-use disinfectant systems alike, a concentration of thedisinfectant may be monitored throughout the process of decontaminatingan instrument. For instance, in a multi-use disinfectant system, aconcentration level of the multi-use disinfectant may be monitored overthe course of multiple disinfection cycles, and the used disinfectantmay either re-used or discarded after a given disinfection cycle basedat least in part on a remaining concentration of the used disinfectant.Examples of versions of reprocessing systems that provide monitoring andre-use of disinfectant solution are disclosed in U.S. Pat. No.8,246,909, entitled “Automated Endoscope Reprocessor GermicideConcentration Monitoring System and Method,” issued Aug. 21, 2012, thedisclosure of which is incorporated by reference herein; in U.S. patentapplication Ser. No. 15/157,800, entitled “Apparatus and Method forReprocessing a Medical Device,” filed on May 18, 2016, the disclosure ofwhich is incorporated by reference herein; and in in U.S. patentapplication Ser. No. 15/157,952, entitled “Apparatus and Method toMeasure Concentration of Disinfectant in Medical Device Reprocessingsystem,” filed on May 18, 2016, the disclosure of which is incorporatedby reference herein.

While a variety of systems and methods have been made and used toreprocess medical devices, it is believed that no one prior to theinventor(s) has made or used the technology as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed the present invention will be better understood from thefollowing description of certain examples taken in conjunction with theaccompanying drawings, in which like reference numerals identify thesame elements and in which:

FIG. 1 depicts a front elevational view of an exemplary reprocessingsystem;

FIG. 2 depicts a schematic diagram of the reprocessing system of FIG. 1,with only a single decontamination basin shown for clarity;

FIG. 3 depicts a cross-sectional side view of proximal and distalportions of an endoscope that may be decontaminated using thereprocessing system of FIG. 1;

FIG. 4 depicts a schematic diagram of a second exemplary reprocessingsystem;

FIG. 5 depicts a schematic diagram of a third exemplary reprocessingsystem;

FIG. 6 depicts a partial schematic diagram of an exemplary variation ofthe reprocessing systems of FIGS. 4-5;

FIG. 7 depicts a flow diagram illustrating an exemplary reprocessingmethod utilized by the reprocessing system of FIG. 6, with the internalchannels of an endoscope undergoing a disinfection stage during whichthe internal channels are filled and purged with disinfectant multipletimes;

FIG. 8 depicts a partial schematic diagram of an exemplary variation ofthe reprocessing system of FIG. 1;

FIG. 9 depicts a flow diagram illustrating another exemplaryreprocessing method utilized by the reprocessing system of FIG. 8, withthe internal channels of an endoscope undergoing a repetitivedisinfecting cycle;

FIG. 10 depicts an enlarged cross-sectional side view of a proximalportion of the endoscope of FIG. 3, schematically showing an internalchannel of the endoscope fluidly connected with a respective flush lineof another exemplary reprocessing system, the flush line having a flushvalve and a flow rate sensor;

FIG. 11 depicts an enlarged cross-sectional side view of a proximalportion of the endoscope of FIG. 3, schematically showing an internalchannel of the endoscope fluidly connected with a respective flush lineof another exemplary reprocessing system, the flush line having a flushvalve and a pressure sensor;

FIG. 12 depicts an enlarged cross-sectional side view of a proximalportion of the endoscope of FIG. 3, schematically showing an internalchannel of the endoscope fluidly connected with a respective flush lineof another exemplary reprocessing system, the flush line having a flushvalve, a pressure sensor, and a flow rate sensor;

FIG. 13 depicts a flow diagram illustrating an exemplary method forfilling and purging an internal channel of an endoscope with theexemplary reprocessing system of FIG. 10 based on fluid flow ratesmeasured by the flow rate sensor;

FIG. 14 depicts a flow diagram illustrating an exemplary method forfilling and purging an internal channel of an endoscope with theexemplary reprocessing system of FIG. 11 based on fluid pressuresmeasured by the pressure sensor;

FIG. 15 depicts a schematic diagram of an exemplary reprocessing systemoperable to fill and purge multiple internal channels of an endoscopesimultaneously while controlling the fill and purge time for eachinternal channel independently via a respective 3-way valve; and

FIG. 16 depicts a schematic diagram of another exemplary reprocessingsystem operable to fill and purge multiple internal channels of anendoscope simultaneously while controlling the fill and purge time foreach internal channel independently via a respective pair of 2-wayvalves.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

It is further understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Thefollowing-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

I. Exemplary Medical Device Reprocessing Apparatus with Single-UseDisinfectant

FIGS. 1-2 show an exemplary reprocessing system (2) that may be used todecontaminate endoscopes and other medical devices that include channelsor lumens formed therethrough. System (2) of this example generallyincludes a first station (10) and a second station (12). Stations (10,12) are at least substantially similar in all respects to provide forthe decontamination of two different medical devices simultaneously orin series. First and second decontamination basins (14 a, 14 b) receivethe contaminated devices. Each basin (14 a, 14 b) is selectively sealedby a respective lid (16 a, 16 b). In the present example, lids (16 a, 16b) cooperate with respective basins (14 a, 14 b) to provide amicrobe-blocking relationship to prevent the entrance of environmentalmicrobes into basins (14 a, 14 b) during decontamination operations. Byway of example only, lids (16 a, 16 b) may include a microbe removal orHEPA air filter formed therein for venting.

A control system (20) includes one or more microcontrollers, such as aprogrammable logic controller (PLC), for controlling decontamination anduser interface operations. Although one control system (20) is shownherein as controlling both decontamination stations (10, 12), thoseskilled in the art will recognize that each station (10, 12) can includea dedicated control system. A visual display (22) displaysdecontamination parameters and machine conditions for an operator, andat least one printer (24) prints a hard copy output of thedecontamination parameters for a record to be filed or attached to thedecontaminated device or its storage packaging. It should be understoodthat printer (24) is merely optional. In some versions, visual display(22) is combined with a touch screen input device. In addition, or inthe alternative, a keypad and/or other user input feature is providedfor input of decontamination process parameters and for machine control.Other visual gauges (26) such as pressure meters and the like providedigital or analog output of decontamination or medical device leaktesting data.

FIG. 2 diagrammatically illustrates just one decontamination station(10) of reprocessing system (2), but those skilled in the art willrecognize that decontamination station (12) may be configured andoperable just like decontamination station (10). It should also beunderstood that reprocessing system (2) may be provided with just onesingle decontamination station (10, 12) or more than two decontaminationstations (10, 12).

Decontamination basin (14 a) receives an endoscope (200) (see FIG. 3) orother medical device therein for decontamination. Any internal channelsof endoscope (200) are connected with flush conduits, such as flushlines (30). Each flush line (30) is connected to an outlet of acorresponding pump (32), such that each flush line (30) has a dedicatedpump (32) in this example. Pumps (32) of the present example compriseperistaltic pumps that pump fluid, such as liquid and air, through theflush lines (30) and any internal channels of endoscope (200).Alternatively, any other suitable kind of pump(s) may be used. In thepresent example, pumps (32) can either draw liquid from basin (14 a)through a filtered drain and a valve (S1); or draw decontaminated airfrom an air supply system (36) through a valve (S2). Air supply system(36) of the present example includes a pump (38) and a microbe removalair filter (40) that filters microbes from an incoming air stream.

A pressure switch or sensor (42) is in fluid communication with eachflush line (30) for sensing excessive pressure in the flush line. Anyexcessive pressure or lack of flow sensed may be indicative of a partialor complete blockage (e.g., by bodily tissue or dried bodily fluids) inan endoscope (200) channel to which the relevant flush line (30) isconnected. The isolation of each flush line (30) relative to the otherflush lines (30) allows the particular blocked channel to be easilyidentified and isolated, depending upon which sensor (42) sensesexcessive pressure or lack of flow.

Basin (14 a) is in fluid communication with a water source (50), such asa utility or tap water connection including hot and cold inlets, and amixing valve (52) flowing into a break tank (56). A microbe removalfilter (54), such as a 0.2 μm or smaller absolute pore size filter,decontaminates the incoming water, which is delivered into break tank(56) through the air gap to prevent backflow. A sensor (59) monitorsliquid levels within basin (14 a). An optional water heater (53) can beprovided if an appropriate source of hot water is not available. Thecondition of filter (54) can be monitored by directly monitoring theflow rate of water therethrough or indirectly by monitoring the basinfill time using a float switch or the like. When the flow rate dropsbelow a select threshold, this indicates a partially clogged filterelement that requires replacement.

A basin drain (62) drains liquid from basin (14 a) through an enlargedhelical tube (64) into which elongated portions of endoscope (200) canbe inserted. Drain (62) is in fluid communication with a recirculationpump (70) and a drain pump (72). Recirculation pump (70) recirculatesliquid from basin drain (62) to a spray nozzle assembly (60), whichsprays the liquid into basin (14 a) and onto endoscope (200). A coarsescreen (71) and a fine screen (73) filter out particles in therecirculating fluid. Drain pump (72) pumps liquid from basin drain (62)to a utility drain (74). A level sensor (76) monitors the flow of liquidfrom pump (72) to utility drain (74). Pumps (70, 72) can besimultaneously operated such that liquid is sprayed into basin (14 a)while basin (14 a) is being drained, to encourage the flow of residueout of basin (14 a) and off of endoscope (200). Of course, a single pumpand a valve assembly could replace dual pumps (70, 72).

An inline heater (80) with temperature sensors (82), upstream ofrecirculation pump (70), heats the liquid to optimum temperatures forcleaning and/or disinfection. A pressure switch or sensor (84) measurespressure downstream of circulation pump (70). In some variations, a flowsensor is used instead of pressure sensor (84), to measure fluid flowdownstream of circulation pump (70). Detergent solution (86) is meteredinto the flow downstream of circulation pump (70) via a metering pump(88). A float switch (90) indicates the level of detergent (86)available. Disinfectant (92) is metered into the flow upstream ofcirculation pump (70) via a metering pump (94). To more accurately meterdisinfectant (92), pump (94) fills a metering pre-chamber (96) undercontrol of a fluid level switch (98) and control system (20). By way ofexample only, disinfectant solution (92) may comprise an activatedglutaraldehyde salutation, such as CIDEX® Activated GlutaraldehydeSolution by Advanced Sterilization Products of Irvine, Calif. By way offurther example only, disinfectant solution (92) may compriseortho-phthalaldehyde (OPA), such as CIDEX® ortho-phthalaldeyde solutionby Advanced Sterilization Products of Irvine, Calif. By way of furtherexample only, disinfectant solution (92) may comprise peracetic acid(PAA).

Some endoscopes (200) include a flexible outer housing or sheathsurrounding the individual tubular members and the like that form theinterior channels and other parts of endoscope (200). This housingdefines a closed interior space, which is isolated from patient tissuesand fluids during medical procedures. It may be important that thesheath be maintained intact, without cuts or other holes that wouldallow contamination of the interior space beneath the sheath. Therefore,reprocessing system (2) of the present example includes means fortesting the integrity of such a sheath. In particular, an air pump(e.g., pump (38) or another pump (110)) pressurizes the interior spacedefined by the sheath of endoscope (200) through a conduit (112) and avalve (S5). In the present example, a HEPA or other microbe-removingfilter (113) removes microbes from the pressurizing air. A pressureregulator (114) prevents accidental over pressurization of the sheath.Upon full pressurization, valve (S5) is closed and a pressure sensor(116) looks for a drop in pressure in conduit (112), which wouldindicate the escape of air through the sheath of endoscope (200). Avalve (S6) selectively vents conduit (112) and the sheath of endoscope(200) through an optional filter (118) when the testing procedure iscomplete. An air buffer (120) smoothes out pulsation of pressure fromair pump (110).

In the present example, each station (10, 12) also contains a drip basin(130) and spill sensor (132) to alert the operator to potential leaks.

An alcohol supply (134), controlled by a valve (S3), can supply alcoholto channel pumps (32) after rinsing steps, to assist in removing waterfrom channels (210, 212, 213, 214, 217, 218) of endoscope (200).

Flow rates in lines (30) can be monitored via channel pumps (32) andpressure sensors (42). If one of pressure sensors (42) detects too higha pressure, the associated pump (32) is deactivated. The flow rate ofpump (32) and its activated duration time provide a reasonableindication of the flow rate in an associated line (30). These flow ratesare monitored during the process to check for blockages in any of thechannels of endoscope (200). Alternatively, the decay in the pressurefrom the time pump (32) cycles off can also be used to estimate the flowrate, with faster decay rates being associated with higher flow rates.

A more accurate measurement of flow rate in an individual channel may bedesirable to detect subtler blockages. To that end, a metering tube(136) having a plurality of level indicating sensors (138) fluidlyconnects to the inputs of channel pumps (32). In some versions, areference connection is provided at a low point in metering tube (136)and a plurality of sensors (138) are arranged vertically above thereference connection. By passing a current from the reference pointthrough the fluid to sensors (138), it can be determined which sensors(138) are immersed and therefore determine the level within meteringtube (136). In addition, or in the alternative, any other suitablecomponents and techniques may be used to sense fluid levels. By shuttingvalve (S1) and opening a vent valve (S7), channel pumps (32) drawexclusively from metering tube (136). The amount of fluid being drawncan be very accurately determined based upon sensors (138). By runningeach channel pump (32) in isolation, the flow therethrough can beaccurately determined based upon the time and the volume of fluidemptied from metering tube (136).

In addition to the input and output devices described above, all of theelectrical and electromechanical devices shown are operatively connectedto and controlled by control system (20). Specifically, and withoutlimitation, switches and sensors (42, 59, 76, 84, 90, 98, 114, 116, 132136) provide input (I) to microcontroller (28), which controls thecleaning and/or disinfection cycles and other machine operations inaccordance therewith. For example, microcontroller (28) includes outputs(O) that are operatively connected to pumps (32, 38, 70, 72, 88, 94,100, 110), valves (S1, S2, S3, S5, S6, S7), and heater (80) to controlthese devices for effective cleaning and/or disinfection cycles andother operations.

As shown in FIG. 3, endoscope (200) has a head part (202). Head part(202) includes openings (204, 206) formed therein. During normal use ofendoscope (200), an air/water valve (not shown) and a suction valve (notshown) are arranged in openings (204, 206). A flexible shaft (208) isattached to head part (202). A combined air/water channel (210) and acombined suction/biopsy channel (212) are accommodated in shaft (208). Aseparate air channel (213) and water channel (214) are also arranged inhead part (202) and merge into air/water channel (210) at the locationof a joining point (216). It will be appreciated that the term “joiningpoint” as used herein refers to an intersecting junction rather thanbeing limited to a geometrical point and, the terms may be usedinterchangeably. Furthermore, a separate suction channel (217) andbiopsy channel (218) are accommodated in head part (202) and merge intosuction/biopsy channel (212) at the location of a joining point (220).

In head part (202), air channel (213) and water channel (214) open intoopening (204) for the air/water valve (not shown). Suction channel (217)opens into opening (206) for the suction valve (not shown). Furthermore,a flexible feed hose (222) connects to head part (202) and accommodateschannels (213′, 214′, 217′), which are connected to air channel (213),water channel (214), and suction channel (217) via respective openings(204, 206). In practice, feed hose (222) may also be referred to as thelight-conductor casing. The mutually connecting air channels (213, 213′)will collectively be referred to below as air channel (213). Themutually connecting water channels (214, 214′) will collectively bereferred to below as water channel (214). The mutually connectingsuction channels (217, 217′) will collectively be referred to below assuction channel (217). A connection (226) for air channel (213),connections (228, 228 a) for water channel (214), and a connection (230)for suction channel (217) are arranged on the end section (224) (alsoreferred to as the light conductor connector) of flexible hose (222).When the connection (226) is in use, connection (228 a) is closed off. Aconnection (232) for biopsy channel (218) is arranged on head part(202).

A channel separator (240) is shown inserted into openings (204, 206).Channel separator (240) comprises a body (242) and plug members (244,246), which occlude respective openings (204, 206). A coaxial insert(248) on plug member (244) extends inwardly of opening (204) andterminates in an annular flange (250), which occludes a portion ofopening (204) to separate channel (213) from channel (214). Byconnecting lines (30) to openings (226, 228, 228 a, 230, 232), liquidfor cleaning and disinfection can be flowed through endoscope channels(213, 214, 217, 218) and out of a distal tip (252) of endoscope (200)via channels (210, 212). Channel separator (240) ensures that suchliquid flows all the way through endoscope (200) without leaking out ofopenings (204, 206); and isolates channels (213, 214) from each other sothat each channel (213, 214) has its own independent flow path. One ofskill in the art will appreciate that various endoscopes havingdiffering arrangements of channels and openings may requiremodifications to channel separator (240) to accommodate such differenceswhile occluding ports in head (202) and keeping channels separated fromeach other so that each channel can be flushed independently of theother channels. Otherwise, a blockage in one channel might merelyredirect flow to a connected unblocked channel.

A leakage port (254) on end section (224) leads into an interior portion(256) of endoscope (200) and is used to check for the physical integritythereof, namely to ensure that no leakage has formed between any of thechannels and the interior (256) or from the exterior to the interior(256).

II. Exemplary Medical Device Reprocessing Method with Single-UseDisinfectant

In an exemplary use of reprocessing system (2), an operator may start byactuating a foot pedal (not shown) to open basin lid (16 a). Each lid(16 a, 16 b) may have its own foot pedal. In some versions, oncepressure is removed from the foot pedal, the motion of lid (16 a, 16 b)stops. With lid (16 a) open, the operator inserts shaft (208) ofendoscope (200) into helical circulation tube (64). End section (224)and head section (202) of endoscope (200) are situated within basin (14a), with feed hose (222) coiled within basin (14 a) with as wide adiameter as possible. Next, flush lines (30) are attached to respectiveendoscope openings (226, 228, 228 a, 230, 232). Air line (112) is alsoconnected to connector (254). In some versions, flush lines (30) arecolor coded, and guide located on station (10) provides a reference forthe color-coded connections.

Depending on the customer-selectable configuration, control system (20)may prompt the operator to enter a user code, patient ID, endoscopecode, and/or specialist code. This information may be entered manually(e.g., through touch screen (22)), automatically (e.g., by using anattached barcode wand), or in any other suitable fashion. With theinformation entered (if required), the operator may then close lid (16a). In some versions, closing lid (16 a) requires the operator to pressa hardware button and a touch-screen (22) button simultaneously toprovide a fail-safe mechanism for preventing the operator's hands frombeing caught or pinched by the closing basin lid (16 a). If either thehardware button or software button is released while lid (16 a) is inthe process of closing, the motion of lid (16 a) stops.

Once lid (16 a) is closed, the operator presses a button on touch-screen(22) to begin the washing/disinfection process. At the start of thewashing/disinfection process, air pump (38) is activated and pressurewithin the body of endoscope (200) is monitored. When pressure reaches apredetermined level (e.g., 250 mbar), pump (38) is deactivated, and thepressure is allowed to stabilize for a certain stabilization period(e.g., 6 seconds). If pressure has not reached a certain pressure (e.g.,250 mbar) in a certain time period (e.g., 45 seconds), the program isstopped and the operator is notified of a leak. If pressure drops belowa threshold (e.g., less than 100 mbar) during the stabilization period,the program is stopped and the operator is notified of the condition.Once the pressure has stabilized, the pressure drop is monitored overthe course of a certain duration (e.g., 60 seconds). If the pressuredrop is faster than a predetermined rate (e.g., more than 10 mbar within60 seconds), the program is stopped and the operator is notified of thecondition. If the pressure drop is slower than a predetermined rate(e.g., less than 10 mbar in 60 seconds), reprocessing system (2)continues with the next step. A slight positive pressure is held withinthe body of endoscope (200) during the rest of the process to preventfluids from leaking in.

A second leak test checks the adequacy of connection to the variousports (226, 228, 228 a, 230, 232) and the proper placement of channelseparator (240). A quantity of water is admitted to basin (14 a) so asto submerge the distal end of endoscope (200) in helical tube (64).Valve (S1) is closed and valve (S7) opened; and pumps (32) are run inreverse to draw a vacuum and to ultimately draw liquid into endoscopechannels (210, 212). Pressure sensors (42) are monitored to make surethat the pressure in any one channel (210, 212) does not drop and/orraise by more than a predetermined amount in a given time frame. If itdoes, it likely indicates that one of the connections was not madecorrectly and air is leaking into channel (210, 212). In any event, inthe presence of an unacceptable pressure drop, control system (20) willcancel the cycle and indicate a likely faulty connection, preferablywith an indication of which channel (210, 212) failed.

In the event that the leak tests are passed, reprocessing system (2)continues with a pre-rinse cycle. The purpose of this step is to flushwater through channels (210, 212, 213, 214, 217, 218) to remove wastematerial prior to washing and disinfecting endoscope (200). To initiatethe pre-rinse cycle, basin (14 a) is filled with filtered water and thewater level is detected by pressure sensor (59) below basin (14 a). Thewater is pumped via pumps (32) through the interior of channels (210,212, 213, 214, 217, 218), directly to drain (74). This water is notrecirculated around the exterior surfaces of endoscope 200 during thisstage. As the water is being pumped through channels (210, 212, 213,214, 217, 218), drain pump (72) is activated to ensure that basin (14 a)is also emptied. Drain pump (72) will be turned off when drain switch(76) detects that the drain process is complete. During the drainingprocess, sterile air is blown via air pump (38) through all endoscopechannels (210, 212, 213, 214, 217, 218) simultaneously, to minimizepotential carryover.

Once the pre-rinse cycle is complete, reprocessing system (2) continueswith a wash cycle. To begin the wash cycle, basin (14 a) is filled withwarm water (e.g., approximately 35° C.). Water temperature is controlledby controlling the mix of heated and unheated water. The water level isdetected by pressure sensor (59). Reprocessing system (2) then addsenzymatic detergent to the water circulating in reprocessing system (2)by means of peristaltic metering pump (88). The volume is controlled bycontrolling the delivery time, pump speed, and inner diameter of thetubing of pump (88). Detergent solution (86) is actively pumpedthroughout the internal endoscope channels (210, 212, 213, 214, 217,218) and over the outer surface of endoscope (200) for a predeterminedtime period (e.g., from one to five minutes, or more particularly aboutthree minutes), by channel pumps (32) and external circulation pump(70). Inline heater (80) keeps the temperature at a predeterminedtemperature (e.g., approximately about 35° C.).

After detergent solution (86) has been circulating for a certain periodof time (e.g., a couple of minutes), the flow rate through channels(210, 212, 213, 214, 217, 218) is measured. If the flow rate through anychannel (210, 212, 213, 214, 217, 218) is less than a predetermined ratefor that channel (210, 212, 213, 214, 217, 218), the channel (210, 212,213, 214, 217, 218) is identified as blocked, the program is stopped,and the operator is notified of the condition. Peristaltic pumps (32)are run at their predetermined flow rates and cycle off in the presenceof unacceptably high pressure readings at the associated pressure sensor(42). If a channel (210, 212, 213, 214, 217, 218) is blocked, thepredetermined flow rate will trigger pressure sensor (42), indicatingthe inability to adequately pass this flow rate. As pumps (32) areperistaltic in the present example, their operating flow rate combinedwith the percentage of time they are cycled off due to pressure willprovide the actual flow rate. The flow rate can also be estimated basedupon the decay of the pressure from the time pump (32) cycles off.

At the end of the wash cycle, drain pump (72) is activated to removedetergent solution (86) from basin (14 a) and channels (210, 212, 213,214, 217, 218). Drain pump (72) turns off when drain level sensor (76)indicates that drainage is complete. During the drain process, sterileair is blown through all channels (210, 212, 213, 214, 217, 218) ofendoscope (200) simultaneously to minimize potential carryover.

After the wash cycle is complete, reprocessing system (2) begins a rinsecycle. To initiate this rinse cycle, basin (14 a) is again filled withwarm water (e.g., at approximately 35° C.). Water temperature iscontrolled by controlling the mix of heated and unheated water. Thewater level is detected by pressure sensor (59). The rinse water iscirculated within channels (210, 212, 213, 214, 217, 218) of endoscope(200) via channel pumps (32); and over the exterior of endoscope (200)via circulation pump (70) and sprinkler arm (60) for a certain period oftime (e.g., one minute). As rinse water is pumped through channels (210,212, 213, 214, 217, 218), the flow rate through channels (210, 212, 213,214, 217, 218) is measured and if it falls below the predetermined ratefor any given channel (210, 212, 213, 214, 217, 218), that channel (210,212, 213, 214, 217, 218) is identified as blocked, the program isstopped, and the operator is notified of the condition.

At the end of the rinse cycle, drain pump (72) is activated to removethe rinse water from basin (14 a) and channels (210, 212, 213, 214, 217,218). Drain pump (72) turns off when drain level sensor (76) indicatesthat drainage is complete. During the drain process, sterile air isblown through all channels (210, 212, 213, 214, 217, 218) of endoscope(200) simultaneously to minimize potential carryover. In some versions,the above-described rinsing and draining cycles are repeated at leastonce again, to ensure maximum rinsing of detergent solution (86) fromthe surfaces of endoscope (200) and basin (14 a).

After reprocessing system (2) has completed the desired number ofrinsing and drying cycles, reprocessing system (2) proceeds to adisinfection cycle. To initiate the disinfection cycle, basin (14 a) isfilled with very warm water (e.g., at approximately 53° C.). Watertemperature is controlled by controlling the mix of heated and unheatedwater. The water level is detected by pressure sensor (59). During thefilling process, channel pumps (32) are off in order to ensure that thedisinfectant solution (92) in basin (14 a) is at the in-useconcentration prior to circulating through channels (210, 212, 213, 214,217, 218) of endoscope (200).

Next, a measured volume of disinfectant solution (92) is drawn fromdisinfectant metering pre-chamber (96) and delivered into the water inbasin (14 a) via metering pump (100). The volume of disinfectantsolution (92) is controlled by the positioning of fill level switch (98)relative to the bottom of metering pre-chamber (96). Meteringpre-chamber (96) is filled until fill level switch (98) detects liquid.Disinfectant solution (92) is drawn from metering pre-chamber (96) untilthe level of disinfectant solution (92) in metering pre-chamber (96) isjust below the tip of metering pre-chamber (96). After the necessaryvolume is dispensed, metering pre-chamber (96) is refilled from thebottle of disinfectant solution (92). Disinfectant solution (92) is notadded until basin (14 a) is filled, so that in case of a water supplyproblem, concentrated disinfectant is not left on endoscope (200) withno water to rinse it. While disinfectant solution (92) is being added,channel pumps (32) are off in order to ensure that disinfectant solution(92) in basin (14 a) is at the desired in-use concentration prior tocirculating through channels (210, 212, 213, 214, 217, 218) of endoscope(200).

The in-use disinfectant solution (92) is actively pumped throughoutinternal channels (210, 212, 213, 214, 217, 218) by pumps (32) and overthe outer surface of endoscope (200) by circulation pump (70). This maybe done for any suitable duration (e.g., at least 5 minutes). Thetemperature of the disinfectant solution (92) may be controlled byin-line heater (80) to stay at a consistent temperature (e.g., about52.5° C.). During the disinfection process, flow through each channel(210, 212, 213, 214, 217, 218) of endoscope (200) is verified by timingthe delivery of a measured quantity of solution through channel (210,212, 213, 214, 217, 218). Valve (S1) is closed, and valve (S7) opened,and in turn each channel pump (32) delivers a predetermined volume toits associated channel (210, 212, 213, 214, 217, 218) from metering tube(136). This volume and the time it takes to deliver the volume, providesa very accurate flow rate through the channel (210, 212, 213, 214, 217,218). Anomalies in the flow rate from what is expected for a channel(210, 212, 213, 214, 217, 218) of that diameter and length are flaggedby control system (20) and the process stopped. As in-use disinfectantsolution (92) is pumped through channels (210, 212, 213, 214, 217, 218),the flow rate through channels (210, 212, 213, 214, 217, 218) is alsomeasured as described above.

At the end of the disinfection cycle, drain pump (72) is activated toremove disinfectant solution (92) solution from basin (14 a) andchannels (210, 212, 213, 214, 217, 218). During the draining process,sterile air is blown through all channels (210, 212, 213, 214, 217, 218)of endoscope (200) simultaneously to minimize potential carryover.

After disinfectant solution (92) has been drained from basin (14 a),reprocessing system (2) begins a final rinse cycle. To initiate thiscycle, basin (14 a) is filled with sterile warm water (e.g., atapproximately 45° C.) that has been passed through a filter (e.g., a 0.2μm filter). The rinse water is circulated within channels (210, 212,213, 214, 217, 218) by pumps (32); and over the exterior of endoscope(200) via circulation pump (70) and sprinkler arm 60) for a suitableduration (e.g., 1 minute). As rinse water is pumped through channels(210, 212, 213, 214, 217, 218), the flow rate through channels (210,212, 213, 214, 217, 218) is measured as described above. Drain pump (72)is activated to remove the rinse water from basin (14 a) and channels(210, 212, 213, 214, 217, 218). During the draining process, sterile airis blown through all channels (210, 212, 213, 214, 217, 218) ofendoscope (200) simultaneously to minimize potential carryover. In someversions, the above-described rinsing and draining cycles are repeatedat least two more times, to ensure maximum rinsing of disinfectantsolution (92) residuals from the surfaces of endoscope (200) and basin(14 a).

After the final rinse cycle is complete, reprocessing system (2) beginsa final leak test. In particular, reprocessing system (2) pressurizesthe body of endoscope (200) and measures the leak rate as describedabove. If the final leak test is successful, reprocessing system (2)indicates the successful completion of the cycles via touch-screen (22).From the time of program completion to the time at which lid (16 a) isopened, pressure within the body of endoscope (200) is normalized toatmospheric pressure by opening vent valve (S5) at a predetermined rate(e.g., valve (S5) opened for 10 seconds every minute).

Depending on customer-selected configuration, reprocessing system (2)may prevent lid (16 a) from being opened until a valid useridentification code is entered. Information about the completed program,including the user ID, endoscope ID, specialist ID, and patient ID arestored along with the sensor data obtained throughout the program. If aprinter is connected to reprocessing system (2), and if requested by theoperator, a record of the disinfection program will be printed. Once avalid user identification code has been entered, lid (16 a) may beopened (e.g., using the foot pedal as described above). Endoscope (200)is then disconnected from flush lines (30) and removed from basin (14a). Lid (16 a) can then be closed using both the hardware and softwarebuttons as described above.

III. Exemplary Medical Device Reprocessing with Reusable Disinfectant

In some instances, it may be desirable to collect and reuse disinfectantone or more times rather than drain and dispose of the disinfectantafter a single use. For example, reusing disinfectant uses less totaldisinfectant over the useful life of reprocessing system (2) and maythus decrease the overall cost of operation. In addition, concentrateddisinfectant, such as the disinfectant provided from disinfectantstorage (92), may have a damaging effect on one or more portions ofreprocessing system (2) until mixed with water as a disinfectantsolution in the desired concentrations. Storing and reusing thedisinfectant solution thus reduces the presence of concentrateddisinfectant and may thus increase the useful life of reprocessingsystem (2).

FIG. 4 shows an exemplary reprocessing system (310) that has adisinfectant storage reservoir (360) from which to pump the disinfectantto basin (14 a) and collect the disinfectant after completion of thedisinfection cycle. Alternative versions of reprocessing system (410,510, 610) discussed herein also include exemplary disinfection storagereservoir (360). It will be appreciated that various aspects of reusingdisinfectant may be used with respect to any of reprocessing systems (2,310, 410, 510, 610) and in any combination as described herein.

As shown in FIG. 4, reprocessing system (310), with second exemplaryreprocessing system (310) includes a primary pump (312) that receivesthe fluid, such as the water and/or disinfectant, and pumps the fluidtoward the collection of valves (336, 338, 340, 342, 344) as discussedabove with respect to various cycles. More particularly, disinfectionvalve (340) is configured to transition between a circulation state anda collection state during the disinfection cycle. With disinfectionvalve (340) in the circulation state, the collection of valves (336,338, 340, 342, 344) is configured to return disinfectant toward flushlines (30) and nozzle assembly (322) for continued circulation duringreprocessing. At the conclusion of the disinfection cycle, disinfectionvalve (340) transitions from the circulation state to the collectionstate and, in conjunction with the remaining collection of valves (336,338, 342, 344), directs the disinfectant into disinfectant storagereservoir (360) for reuse in future disinfection cycles. As used herein,the term “disinfectant” refers to concentrated disinfectant or anysolution including disinfectant at any concentration. The term“disinfectant” is thus not intended to unnecessarily limit the inventionto a particular concentration or solution of disinfectant.

Reprocessing system (310) further includes disinfectant pump (94) influid communication between disinfectant storage reservoir (360) andbasin (14 a). Disinfectant pump (94) thus pumps the disinfectantdirectly into basin (14 a). Check valve (330) is also fluidly connectedbetween basin (14 a) and disinfectant pump (94) and is configured toinhibit fluid within basin (14 a) from flowing backward toward pump(94). In some versions, disinfectant storage reservoir (360) is in theform of a break tank such that primary pump (312) and disinfectant pump(94) are configured to individually and/or simultaneously interact withdisinfectant storage reservoir (360). However, it will be appreciatedthat alternative couplings and other features may be used to fluidlycouple any form of disinfectant storage reservoir (360) withinreprocessing system (310) for collecting and reusing disinfectant. Theinvention is thus not intended to be limited to the particulardisinfectant storage reservoir (360).

Reprocessing system (310) of this example may be readily incorporatedinto stations (10, 12) (see FIG. 1) with basins (14 a, 14 b). Basin (14a) shown in FIG. 4 thus receives water from water source (50) anddischarges all water therefrom via drain (74), as discussed above.Exemplary basin (14 a) includes a plurality of flush lines (30)extending therein and a nozzle assembly (322) having a plurality ofnozzles (324). Each flush line (30) and nozzle (324) is configured todirect the water and/or any additive solution, which may be generallyreferred to as the fluid, toward endoscope (200) (see FIG. 3) withinbasin (14 a) for reprocessing. As discussed above, flush lines (30) areconfigured to discharge the fluid into respective channels (210, 212,217, 218) (see FIG. 3), at respective predetermined conduit flow ratesparticularly configured for each respective channel (210, 212, 217, 218)(see FIG. 3). To this end, primary pump (312) pumps a predeterminedsupply flow rate of the fluid collectively to flush lines (30) via acommon manifold (326) that is fluidly coupled therebetween.

A plurality of flush valves (314, 316, 318, 320) are positionedrespectively in each flush line (30) and are collectively configured tobalance fluid flow from primary pump (312) such that each flush line(30) discharges fluid therefrom at respective predetermined conduit flowrates. In some versions, flush lines (30) deliver four differentrespective predetermined conduit flow rates of fluid to channels (210,212, 217, 218) (see FIG. 3). In some other versions, one or more of therespective predetermined conduit flow rates are approximately equivalentto accommodate an alternative medical device. In any case, any number offlush lines (30) configured to deliver fluid at any predeterminedconduit flow rates may be used to accommodate one or more types ofmedical devices.

Water source (50) delivers the water to a three-way introduction valve(328), which directs the water through filter (54), check valve (330),and two-way valve (332) into basin (14 a). As in reprocessing system (2)(see FIG. 2), the water may be collected to a desirable amount asdetected by level sensors (59 a, 59 b, 76). The water drains from basin(14 a) and may pass through heater (80) and two-way valve (334) to reachprimary pump (312) for distribution toward flush lines (30) and nozzleassembly (322). More particularly a collection of two-way valves (336,338, 340, 342, 344) are fluidly connected downstream of primary pump(312) to either allow or inhibit fluid flow therethrough for variouscycles as discussed herein. For example, flush valve (336) and nozzlevalve (338) are configured to control flow respectively toward flushlines (30) and nozzle assembly (322).

In addition, disinfectant valve (340), drain valve (342), and returnvalve (344) are respectively configured to provide disinfection ofendoscope (200), drainage from reprocessing system (310), andself-disinfection of reprocessing system (310). Disinfection andself-disinfection will be discussed below in additional detail. In thepresent example, disinfection valve (340), drain valve (342), and returnvalve (344) are presumed fully closed so as to direct the entirety ofthe predetermined supply flow of the fluid through the opened flush andnozzle valves (336, 338). However, the collection of valves (336, 338,340, 342, 344) may be fully opened, partially opened, and/or fullyclosed so as to direct the fluid in any one of a plurality of desirableratios to complete the cycles of reprocessing. The invention is thus notintended to be limited specifically to the combination of open and/orclosed valves as described herein.

Downstream of flush valve (336), additive storages, such as detergentand alcohol storage (86, 134), and detergent metering pump (88), analcohol metering pump (346), and a gas pump (38) fluidly connect to bereceived with or in place of water flowing toward flush lines (30). Aseries of optional two-way valves (348) may be fluidly connecteddownstream of pumps (88, 346, 38) for additional flow control of variousadditives. In any case, the fluid, such as water, is received withinmanifold (326) at the predetermined supply flow rate. As shown inexemplary reprocessing system (310) of FIG. 4, each of the four flushlines (30) fluidly connects to manifold (326) and extends into basin (14a) for connection with channels (210, 212, 217, 218) (see FIG. 3) ofendoscope (200). More particularly, each flush line (30) includes acoupling port (350) within basin (14 a) that is configured to fluidlyseal against endoscope (200) for fluidly coupling channels (210, 212,217, 218) (see FIG. 3) with respective flush lines (30).

As briefly discussed above, each flush line (30) includes its respectiveflush valve (314, 316, 318, 320) configured to balance fluid flows alongflush lines (30) according to the predetermined conduit flow rates. Insome versions, flush valves (314, 316, 318, 320) are in the form oforifice valves that are sized relative to each to each other to createpredetermined restriction on the fluid entering manifold (326) accordingto the predetermined supply flow rate. As the pressure within themanifold (326) distributes equally through flush lines (30),predetermined conduit flow rates of fluid flow through each respectiveflush valve (314, 316, 318, 320) and discharge from coupling ports(350). Alternatively, flush valves (314, 316, 318, 320) may eachcomprise a variable valve configured to provide a discrete,predetermined flow rate so that the operator may adjust various flowrates to accommodate differing medical devices in reprocessing system(310).

Furthermore, nozzle valve (338) also receives the fluid, such as water,from primary pump (312) and directs the fluid toward nozzle assembly(322). Each nozzle (324) is generally identical in the present exampleand configured to discharge fluid onto the exterior of endoscope (200)(see FIG. 3) within basin (14 a) at approximately equivalentpredetermined nozzle flow rates. To this end, nozzle valve (338) isconfigured to further balance the predetermined supply flow rate offluid with flush valves (314, 316, 318, 320) such that each nozzle (324)and fluid line (30) discharges fluid therefrom according to itspredetermined conduit flow rate and predetermined nozzle flow rate,respectively. Similar to flush valves (314, 316, 318, 320), nozzle valve(338) may also be a variable valve configured to set to a discrete,predetermined flow rate so that the operator may adjust various flowrates to accommodate differing medical devices in reprocessing system(310). Alternatively, nozzle valve (338) in an open position may providenegligible resistance such that the various predetermined flow rates arebalanced simply by restriction in each respective nozzle (324).

In use, reprocessing system (310) receives water from water supply (50)into basin (14 a). Alternatively, basin (14 a) may receive one of theadditives alone or in combination with the water. In any case, the fluidcollected within basin (14 a) is received within primary pump (312) andpumped therefrom at the predetermined supply flow rate. The collectionof valves (338, 340, 342, 344) are generally configured to direct thefluid at the predetermined supply flow rate toward manifold (326) andnozzle assembly (322). The fluid flowing toward manifold (326) may alsoreceive one of the additives, such as detergent, as discussed above inadditional detail.

A predetermined portion of the fluid flows into manifold (326), while aremaining predetermined portion of the fluid flows through nozzle valve(338). Flush valves (336) and nozzle valve (338) generate predeterminedrestriction in each respective flush line (30) in order to direct fluidflow along each flush line (30) with at least two different respectivepredetermined conduit flow rates. Such predetermined restriction andrestriction results in flush valves (336) and nozzle valve (338)apportioning the fluid flow therethrough according to the variouspredetermined flow rates. For example, flush valves (336) and nozzlevalve (338) may be configured to direct fluid along four flush lines(30) with four different respective predetermined conduit flow rates.Once balanced accordingly, the fluid discharges from each coupling port(350) and into respective channels (210, 212, 217, 218) (see FIG. 3)with the predetermined conduit flow rates for reprocessing endoscope(200) (see FIG. 3). It will be appreciated that generating suchpredetermined flow rates via valves (336, 338) may be used in any cycleof reprocessing described herein and is not intended to limit theinvention to any specific reprocessing cycle.

Reprocessing system (310) of the present example includes only oneprimary pump (312) supplying the predetermined supply flow rate of fluidto each flush line (30) and nozzle (324). However, it will beappreciated that any number of pumps may be used in combination, such asin series or parallel, to direct fluid as discussed above. It willtherefore be appreciated that the invention is not intended tounnecessarily be limited to only one primary pump (312). By way offurther example only, reprocessing system (310) may be configured andoperable in accordance with at least some of the teachings of U.S.patent application Ser. No. 15/157,800, entitled “Apparatus and Methodfor Reprocessing a Medical Device,” filed on May 18, 2016, thedisclosure of which is incorporated by reference herein.

FIG. 5 shows another exemplary reprocessing system (310′), which hasanother exemplary disinfectant storage reservoir (360′) fluidlyconnected between disinfectant valve (340) and pump (94). Disinfectantstorage reservoir (360′) is generally similar to disinfectant storagereservoir (360) (see FIG. 4), but also includes additional features forfurther preparing and maintaining the disinfectant for reprocessing.Specifically, disinfectant storage reservoir (360′) includes adisinfectant heater (361′) that is configured to heat the disinfectantfor reprocessing. In some versions, disinfectant heater (361′) isconfigured to pre-heat the disinfectant in anticipation of use in orderto more quickly heat the fluid circulating through reprocessing system(310′) for reasons discussed below in additional detail. Alternativelyor in addition, disinfectant heater (361′) may heat the disinfectantwhile flowing from disinfectant storage reservoir (360′) toward pump(94) for use. In either case, disinfectant heater (361′) may beconfigured to heat the fluid in conjunction with heater (80) forcollectively heating the fluid as it flows through reprocessing system(310′).

Disinfectant storage reservoir (360′) further includes a maximum levelsensor (362′), a minimum level sensor (363′), and a temperature sensor(364′) for monitoring the disinfectant flowing through and/or containedwithin disinfectant storage reservoir (360′). Maximum and minimum levelsensors (362′, 363′) are configured to approximate the amount ofdisinfectant contained within disinfectant storage reservoir (360′) andcommunicate with another system, such as control system (20) (see FIG.1). For example, maximum and minimum level sensors (362′, 363′) andcontrol system (20) (see FIG. 1) collectively monitor the amount ofdisinfectant to be above the maximum level, below the minimum level, orbetween the maximum and minimum levels, which is generally desired foroperation. Temperature sensor (364′) also communicates with anothersystem, such as control system (20) (see FIG. 1), to monitor thetemperature of the disinfectant.

In order to further monitor the disinfectant, reprocessing system (310′)also includes a disinfectant concentration measuring subsystem (365′)that is configured to receive the disinfectant from at least onelocation within reprocessing system (310′) for sampling and testing. Tothis end, disinfectant concentration measuring subsystem (365′) of thepresent example receives the disinfectant samples from at least one offlush lines (30). In another example, disinfectant concentrationmeasuring subsystem (365′) may receive disinfectant samples from alocation downstream of disinfection valve (340). Disinfectantconcentration measuring subsystem (365′) is configured to test thereceived samples of disinfectant for a concentration of disinfectantpresent within the fluid flowing through reprocessing system (310′). Inthe event that the measured concentration of disinfectant is not withina predetermined range of concentration or is below a predeterminedminimum concentration, disinfectant concentration measuring subsystem(365′) notifies the operator accordingly. Such measurement andnotification may be further aided by communication with control system(20) (see FIG. 1) discussed above in greater detail, which may terminatereprocessing of the instrument. Prior to and following the disinfectantconcentration measurement, disinfectant concentration measuringsubsystem (365′) may be rinsed with water received from an outlet sideof filter (54), which water may then drain from subsystem (365′) todrain sump (130). As shown in FIG. 5, an inlet side of filter (54) ofthe present example communicates directly with drain sump (130) via aseparate fluid line for removal of air from filter (54).

Upon completion of sampling and testing, the disinfectant drains todrain sump (130) such that disinfectant concentration measuringsubsystem (365′) is available for further use. It will be appreciatedthat various devices and method for measuring disinfectant concentrationand notifying the operator may be used as described herein and, as such,the invention is not intended to be unnecessarily limited to anyparticular disinfectant concentration measuring subsystem. By way offurther example only, disinfectant concentration measuring subsystem(365′) may be configured and operable in accordance with at least someof the teachings of U.S. patent application Ser. No. 15/157,952,entitled “Apparatus and Method to Measure Concentration of Disinfectantin Medical Device Reprocessing System,” filed on May 18, 2016, thedisclosure of which is incorporated by reference herein.

Additional monitoring is provided in reprocessing system (310′) by abasin temperature sensor (366′), a drain sump overflow sensor (367′),and a plurality of flow sensors (368′). Basin temperature sensor (366′)is generally configured to measure the temperature of fluid therein,while drain sump overflow sensor (367′) is configured to measure anexcess of fluid collected within drain sump (130) for alerting theoperator and canceling the reprocessing process. Each flow sensor (368′)is configured to measure the volumetric flow rate of fluid flowingtherethrough for monitoring the overall circulation of fluid throughreprocessing system (310′). Each of temperature sensor (366′), drainsump overflow sensor (367′), and flow sensors (368′) may communicatewith control system (20) (see FIG. 1) for collective operation with anyone or more of the sensors discussed herein for using reprocessingsystem (310). However, it will be appreciated that alternative devicesand methods of monitoring reprocessing system (310′) may be used andthat the invention described herein is not intended to be unnecessarilylimited to reprocessing system (310′).

IV. Exemplary Medical Device Reprocessing Apparatus and Method forRecurring Flow Cycles

In some instances, it may be desirable to increase the bioburdenreduction within an internal channel of an endoscope by directing a flowof various solutions, liquids, and/or pressurized air through theendoscope. Although depositing detergents and/or disinfectants withinthe internal channel of an endoscope may lower the bioburden level ofthe channels, decreasing the bioburden level in internal channels ofendoscopes to a desired level may be particularly difficult due to thesmall diameters and sometimes irregular profiles of the internalchannels. In some cases, simply maintaining a disinfectant or detergentwithin the internal channels of an endoscope for a specified durationmay significantly increase the time required to achieve the desiredlevel of bioburden reduction efficacy. In some instances, an endoscope(200) may include an elevator channel with a cable or wire positionedtherein, such as in a duodenoscope. With the presence of a cable or wirecontained within the elevator channel, an additional restriction iscreated as the volume of disinfectant that can flow through the elevatorchannel is limited. Where the cable is in the form of a twisted cable,numerous gaps and crevices are present that are capable of housingvarious bioburdens and other particles.

Internal channels (210, 212, 213, 214, 217, 218) of endoscopes (200),and elevator channels of duodenoscopes, may be formed of a material thatis more chemical-resistant than the outer surfaces of endoscopes (200).As merely an illustrative example, internal channels (210, 212, 213,214, 217, 218) may be formed of Teflon or metals that have a highertolerance to chemical or heat exposure. Accordingly, internal channels(210, 212, 213, 214, 217, 218) are capable of being exposed to a higherconcentration of disinfectant or detergent and/or a higher temperature.Additionally, due to the narrow configuration, and sometimes irregularprofile, of internal channels (210, 212, 213, 214, 217, 218), utilizinga higher level of concentration may be desirable to effectively achievebioburden reduction within internal channels (210, 212, 213, 214, 217,218) due to the greater difficulty in disinfecting internal channels(210, 212, 213, 214, 217, 218) than the outer surface of endoscope(200).

Reprocessing apparatuses that alternate between directing varyingtreatment solutions through an endoscope (200) may be desirable toincrease the bioburden reduction efficacy of the internal channels (210,212, 213, 214, 217, 218). Providing a recurring cycle where variousliquids, detergents, and disinfectants flow through internal channels(210, 212, 213, 214, 217, 218) of endoscopes (200) may be beneficial tolower the bioburden level within the channel (210, 212, 213, 214, 217,218). As these types of liquids flow reiteratively through internalchannels (210, 212, 213, 214, 217, 218), a shear stress is generated onthe inner walls of internal channels (210, 212, 213, 214, 217, 218)proportional to the flow rate. This shear stress has a destructiveeffect on bioburden residing on the channel walls. Thus, it may bedesirable to direct pressurized air through internal channels (210, 212,213, 214, 217, 218) to increase the flow rate of the liquid and displacethe liquid contained therein to achieve higher shear stresses andconsequently greater bioburden reduction effects. The flow rate of theliquid in the channel (210, 212, 213, 214, 217, 218) significantlyincreases as more liquid is displaced with air. The amount of flow rateis inversely proportional to the length of channels (210, 212, 213, 214,217, 218), as demonstrated in the Hagen-Poiseuille's equation providedbelow:

${Q = {\frac{dV}{dt} = {{v\pi R}^{2} = {{\frac{{\pi R}^{4}}{8n}\left( {- \frac{\Delta P}{\Delta x}} \right)} = {\frac{{\pi R}^{4}}{8n}\frac{{\Delta P}}{L}}}}}};$

where in compatible units (e.g., SI): “Q” is the volumetric flow rate;“V(t)” is the volume of the liquid transferred as a function of time,“t”; “v” is mean fluid velocity along the length of the tube; “x” is thedistance in direction of flow; “R” is the internal radius of the tube;“ΔP” is the pressure difference between the two ends; “n” is the dynamicfluid viscosity; and “L” is the length of the tube. In variousapplications, the fluid pressure in the channel may be limited toapproximately 30 psi to prevent damage to the channel walls.

In this instance, the shear stress of the inner wall is increased andthe amount of bioburden removal is enhanced. The amount of shear stressis proportional to the flow rate, as shown by the following formula

$\begin{matrix}{{\tau = {\frac{32\mu}{{\pi D}^{3}}Q}};} & (3)\end{matrix}$where “μ” is the viscosity of water and “Q” is the flow rate.

Repeatedly directing a stream of pressurized air through the internalchannels (210, 212, 213, 214, 217, 218), once a detergent ordisinfectant solution has passed therethrough, may be further desirableto flush the remaining liquid out of endoscope (200) to ensure anyremnants from a prior cycle is substantially removed. By repeatedlyfilling and purging the internal channels (210, 212, 213, 214, 217, 218)of an endoscope (200), the total time required to remove a certain levelof bioburden may be reduced; and in any subsequent cycle introducing ahigh concentration of disinfectant, that disinfectant is less likely tobe diluted by residual fluid in channels (210, 212, 213, 214, 217, 218).The following description provides various examples of a reprocessingsystem that is configured to deliver a reiterative cycle of varioussubstances and solutions to the internal channels of a medicalinstrument. A reprocessing system may include a single pump assemblythat is configured to deliver the various substances, such as detergent,water, pressurized air, etc. In this instance, the reprocessing systemmay be configured to selectively open and close a series of valves toindividually deliver the various substances through the single pumpassembly. Alternatively, as shown below, a reprocessing system mayinclude a separate, dedicated pump to deliver each varying substance tointernal channels (210, 212, 213, 214, 217, 218). Although individualpumps are described below, it should be understood that a single pumpsystem or pump assembly may be utilized to implement the reprocessingmethods detailed below.

A. Medical Device Reprocessing Apparatus and Method Using Pre-DilutedDisinfectant

In some instances, as previously discussed above, it may be desirable touse the same disinfectant for multiple disinfection cycles of theinternal channels (210, 212, 213, 214, 217, 218) of an endoscope (200).As used herein, the term “disinfection cycle” refers to one instance offilling an internal channel (210, 212, 213, 214, 217, 218) withdisinfectant and subsequently purging the disinfectant from the internalchannel. A disinfection cycle is thus one variant of a fill and purgecycle (which may also be referred to as a “purge and fill cycle”)implemented during the reprocessing of internal channels (210, 212, 213,214, 217, 218) of an endoscope (200). While fill and purge cycles aredescribed herein primarily in the context of the disinfection stage ofinstrument reprocessing, during which multiple disinfection cycles maybe completed, fill and purge cycles may also be implemented throughoutother stages of instrument reprocessing, such as during a washing andrinsing stage.

Performing multiple disinfection cycles for a given internal channel(210, 212, 213, 214, 217, 218) using the same volume of disinfectant maybe desirable to provide adequate disinfection of the internal channelwhile reducing the need for additional disinfectant for each subsequentdisinfection cycle. Reutilizing disinfectant for multiple disinfectioncycles may thus minimize costs while achieving a sufficient level ofbiocidal activity. During each subsequent disinfection cycle followingan initial disinfection cycle, the dilution factor of the disinfectantmay decrease dramatically. The concentration of the disinfectant in thechannel (210, 212, 213, 214, 217, 218) can be estimated using thefollowing formula: C_(n)=C_(i)−(C_(i)×R^(n)), where “C_(n)” is thedisinfectant concentration in the channel after “n” number of purge andfill disinfection cycles; “C_(i)” is the initial undiluted disinfectantconcentration; and “R” is the remaining percentage of fluid in thechannel after purging. The table below shows the channel disinfectantconcentration at different parameters:

Number Remaining Remaining Remaining Remaining Remaining of Purge & % %% % % Fill 10% 20% 30% 40% 50% 1 90 80 70 60 50 2 99 96 91 84 75 3 99.999.2 97.3 93.6 87.5

The following description provides various examples of a reprocessingsystem and method configured to adequately decontaminate the internalchannels (210, 212, 213, 214, 217, 218) of an endoscope (200) through arecurring disinfection cycles. Ultimately, providing a methodicalapproach to disinfecting the inner components of an endoscope (200) maybe beneficial to ensure the proper degree of bioburden reduction isachieved in each instance. It should be understood that the reprocessingmethod described below may be readily incorporated into any of thevarious reprocessing systems (2, 310, 310′) and to any of the variousendoscopes (200) described above. Other suitable ways in which thebelow-described reprocessing method may be used will be apparent tothose of ordinary skill in the art in view of the teachings herein.

FIG. 6 shows a block schematic of an exemplary reprocessing system (410)including a disinfectant storage (411), a detergent storage (415), anair supply system (421), and a water supply (425). Except as otherwisedescribed below, reprocessing system (410), disinfectant storage (411),detergent storage (415), air supply system (421), and water reservoir(425) are configured and operable just like reprocessing system (2, 310,310′), disinfectant storage (92, 360), disinfectant (86), air supplysystem (36), and water supply (50), respectively, described above.Internal channels (420) of an endoscope (400) are in fluid communicationwith disinfectant storage (411), detergent storage (415), air supplysystem (421) and water reservoir (425) via flush lines (444).Reprocessing system (410) is operable to deliver disinfectant solution(92), detergent solution (86), air and water to internal channels (420)of endoscope (400) individually and sequentially. While only oneendoscope (400) is shown as being reprocessed in reprocessing system(410), it should be understood that reprocessing system (410) may becapable of reprocessing more than one endoscope (400) simultaneouslyand/or in a sequence.

Flush lines (444) include a flush valve (446) for each channel (420)operatively connected to reprocessing system (410). Flush valves (446)are positioned downstream of disinfectant storage (411), detergentstorage (415), air supply system (421), and water reservoir (425). Inthe present example, disinfectant storage (411) is in fluidcommunication with a disinfectant pump (412), a flow sensor (413) and acheck valve (414) in sequence, such that disinfectant pump (412) isconfigured to transfer disinfectant (92) from disinfectant storage (411)to flow sensor (413) and through check valve (414) via flush lines(444). In this instance, disinfectant solution (92) is a highconcentrate disinfectant that is capable of providing adequate bioburdenreduction within internal channels (420).

Flow sensor (413) is operable to monitor the flow of concentrateddisinfectant (92) delivered from disinfectant pump (412) to internalchannels (420) of endoscopes (400). Control system (20) of reprocessingsystem (410) is configured to execute a control algorithm (see FIG. 7)to open flush valve (446), which is in fluid connection with endoscope(400), and retrieve the data monitored by flow sensor (413). Controlsystem (20) is operable to terminate fluid communication betweendisinfectant pump (412) and endoscope (400) when the data obtained fromflow sensor (413) indicates that internal channel (420) has received asufficient amount of concentrated disinfectant (92) by closing off flushvalve (446).

Similarly, detergent storage (415) is in fluid communication with adetergent pump (416), a flow sensor (417) and a check valve (418) insequence, such that detergent pump (416) is configured to transferdetergent solution (86) to flow sensor (417) and through check valve(418) via flush lines (444). Flow sensor (417) is operable to monitorthe elapsed duration as detergent (86) is delivered from detergent pump(416) to internal channels (420) of endoscope (400). Reprocessing system(410) is configured to terminate the fluid communication betweendetergent pump (416) and flush valve (446) once the elapsed duration asmonitored by flow sensor (417) has reached a predetermined timethreshold. Alternatively, or in conjunction, reprocessing system (410)is configured to cease operation of detergent pump (416) from pumpingdetergent (86) to internal channels (420). In each instance,reprocessing system (410) is configured to close flush valve (446) wheninternal channel (420) has received a sufficient amount of detergent(86) therein, as sensed by flow sensor (417).

Air supply system (421) is in communication with an air pump (422), afilter (423) and a check valve (424). Air pump (422) is configured topush pressurized air from air supply system (421) through filter (423)and check valve (424), thereby delivering a stream of air into andthrough internal channels (420) of endoscope (400). Filter (423) isoperable to filter and remove microbes from the incoming air streamextracted from air supply system (421). In some illustrative examples,filter (423) comprises a HEPA microbe-removing filter. In some versions,reprocessing system (410) may exclude filter (423) in communication withair pump (422) and check valve (424). Water reservoir (425) is in fluidcommunication with a water pump (426), a flow sensor (427) and a checkvalve (428). Water pump (426) is configured to pump water from waterreservoir (425) to flow sensor (427) and through check valve (428) viaflush lines (444). Reprocessing system (410) is operable to measure thequantity of water delivered from water pump (426) to internal channel(420) of endoscope (400), based on data from flow sensor (427).Reprocessing system (410) is further configured to close flush valve(446) upon determining that internal channel (420) has received asufficient amount of water therein, as sensed by flow sensor (427).

Reprocessing system (410) further includes basin (14 a) in fluidcommunication with internal channels (420) of endoscope (400) via flushlines (444). Basin (14 a) is operable to receive any fluids or airreleased from internal channels (420). Further, basin (14 a) is in fluidcommunication with water pump (426) via an independent flush line (444)such that water pump (426) is operable to draw the released fluidswithin basin (14 a), which may include disinfectant (92), to water pump(426). In that regard, it will be appreciated that water pump (426) ofthe present version may be configured to direct fluids to internalchannels (420) at higher flow rates than disinfectant pump (412), suchthat water pump (426) is better suited to recirculate fluids thandisinfectant pump (412). In the present version, released fluid isrecycled through reprocessing system (410) when water pump (426)activates to pump the released fluid, such as disinfectant (92), andoptionally a new volume of water, through flow sensor (427), check valve(428) and into internal channels (420). For example, with basin (14 a)holding previously used disinfectant (92) recently released frominternal channels (420), basin (14 a) is operable to transfer thepreviously used disinfectant (92) through flush line (444) to water pump(426) for reuse. In this instance, water pump (426) is configured topump the previously used disinfectant (92) and any new water intointernal channels (420) for an additional disinfection cycle.Simultaneously, disinfectant pump (412) may be configured to obtain anew volume of disinfectant (92) from disinfectant storage (411) formixture and delivery with the previously used disinfectant (92) beingdelivered from basin (14 a) to internal channels (420) by water pump(426). Though not shown, in an exemplary alternative configurationdisinfectant pump (412) may be suitably configured to recirculatedisinfectant (92) received from basin (14 a). In such case, disinfectantpump (412) may be fluidly connected with basin (14 a) via a flush linesimilar to flush line (444), which may include a proportional valvesimilar to valve (450) described below.

As seen in FIG. 6, reprocessing system (410) includes a first variablevalve (448) (also referred to as a “proportional valve”) in line betweendisinfectant storage (411) and disinfectant pump (412) and a secondvariable valve (450) (or “proportional valve”) between basin (14 a) andwater pump (426). Reprocessing system (410) is operable to selectivelyopen and close variable valves (448, 450) to draw disinfectant (92) fromdisinfectant storage (411) and separately, or simultaneously, pull fluidfrom basin (14 a), respectively. For instance, with first variable valve(448) in an open state and with second variable valve (450) in a closedstate, disinfectant pump (412) pulls fresh disinfectant (92) fromdisinfectant storage (411) and water pump (426) pulls water from waterfeed (425) without pulling fluids from basin (14 a). With first variablevalve (448) in a closed state and with second variable valve (450) in anopen state, water pump (426) pulls fluids from basin (14 a), includingrecycled disinfectant (92), and disinfectant pump (412) does not pullfresh disinfectant (92) from disinfectant storage (411).

In some versions, reprocessing system (410) is configured to maintainvariable valves (448, 450) simultaneously open. In this instance, unlikeflush valves (446), variable valves (448, 450) include variable orificesthat are configured to be selectively adjusted. Reprocessing system(410) is configured to adjust the size of the orifice of variable valves(448, 450) to thereby selectively control the amount of disinfectant(92) pulled from disinfectant storage (411) by disinfectant pump (412)and the amount of released fluids drawn from basin (14 a) by water pump(426). In this instance, reprocessing system (410) is operable tocooperatively manipulate the opening dimensions of variable valves (448,450) to thereby deliver varied doses and/or concentrations ofdisinfectant (92) to internal channels (410) during subsequentdisinfecting cycles. Although not shown, it should be understood thatreprocessing system (410) may include a single pump assembly such thatthe same pump assembly is configured to deliver detergent (86), water,pressurized air, and disinfectant (92). In this instance, reprocessingsystem (410) is configured to selectively open and close a series offlush valves (446) to individually deliver the various substances withthe single pump assembly.

FIG. 7 shows a flow diagram illustrating steps of an exemplaryreprocessing method (480) that may be used by reprocessing system (410)to perform a predetermined number of fill and purge cycles of internalchannels (420) of endoscope (400). At step (482), reprocessing system(410) initiates detergent pump (412) to deliver detergent solution (86)to endoscope (400) via flush lines (444). Reprocessing system (410) isconfigured to deliver detergent (86) through internal channels (420) ata predetermined flow rate. At step (484), as detergent (86) istransferred from detergent storage (415) to endoscope (400), flow sensor(417) measures an elapsed duration of flow as detergent pump (416)actively pumps detergent (86) toward internal channels (420).Reprocessing system (410) ceases operation of detergent pump (416) whenthe elapsed flow time equals a predetermined time threshold fordetergent delivery. Subsequently, at step (486), reprocessing system(410) initiates water pump (426) to deliver water to endoscope (400) viaflush lines (444) and through internal channels (420), to thereby rinseany remaining detergent (86) out from internal channels (420) and intobasin (14 a). In this instance, flow sensor (427) measures an elapsedduration of flow as water pump (426) actively pumps water towardinternal channels (420). Reprocessing system (410) ceases operation ofwater pump (426) when the elapsed flow time equals a predetermined timethreshold for rinsing. In other examples, reprocessing system (410) maycontrol pumps (416, 426) and/or flush valves (446) to cease the flow ofdetergent and water to internal channels (420) when the respective flowsensor (417, 427) observes a predetermined flow rate of the respectivefluid.

At step (488), reprocessing system (410) initiates air pump (422) tosend pressurized air from air supply system (421) through filter (423)and into endoscope (400). The stream of air passes through internalchannels (420) thereby purging internal channels (420) of any residualdetergent (86) or water contained therein. Air pump (422) continues toflow pressurized air through internal channels (420) until a specifiedflow duration elapses, signaling for reprocessing system (410) to ceaseoperation of air pump (422). Reprocessing system (410) terminates airpump (422) once the elapsed flow time has reached a predetermined timethreshold for air purging. At step (490), with air pump (422) inactive,disinfectant pump (412) beings to pump high concentrate disinfectant(92) to internal channels (420) of endoscope (400) simultaneously.

Reprocessing system (410) monitors the volume of disinfectant (92)transferred from disinfectant storage (411) to endoscope (400) andceases operation of disinfectant pump (412) when the volume deliveredsubstantially equals a predetermined threshold, as seen at step (492).Reprocessing system (410) closes all flush valves (446) simultaneouslywith the deactivation of disinfectant pump (412). In this instance, asseen at step (494), reprocessing system (410) evaluates whether internalchannels (420) of endoscope (400) have stored the high concentratedisinfectant (92) for a minimum dwell time. As merely an illustrativeexample, the predetermined dwell time can range between approximately 10seconds to 30 seconds. Although not shown, it should be understood thatin some versions reprocessing system (410) may forego holding the highconcentrate disinfectant (92) in the internal channels (420) for theminimum dwell time. Instead, flush valves (446) may remain open afterthe deactivation of disinfectant pump (412) and reprocessing system(410) may initiate water pump (526) and air pump (422), respectively insequential order as described above.

At step (496), once reprocessing system (410) has determined thatinternal channels (420) have maintained disinfectant (92) for theminimum dwell time, flush valves (446) are reopened and air pump (422)is reactivated. In this instance, pressurized air is flowed throughinternal channels (420) to thereby purge disinfectant (92) fromendoscope (400). In other versions, water may be directed throughinternal channels (420) to purge disinfectant (92). The flow rate ofdisinfectant (92) being released from within internal channels (420)into basin (14 a) is increased due to the flow of pressurized air (orwater), thereby enhancing the bioburden removal. At step (497), withdisinfectant (92) released into basin (14 a) and contained therein,reprocessing system (410) determines whether the above described filland purge process defining a disinfection cycle has been performed apredetermined “n” number of times. By way of example only, thepredetermined “n” number of times may be two times, three times, fourtimes, five times, six times, or more times. For instance, in someversions “n” times may be in the range of 16 times to 33 times, or more.Upon the determination by reprocessing system (410) that additional filland purge disinfection cycles remain to be completed, reprocessingsystem (410) transfers the previously used disinfectant (92) from basin(14 a) to water pump (426) for subsequent use in the next cycle, as seenin step (498).

In this instance, reprocessing system (410) will continue to performstep (490) through step (497) until reprocessing system (410) determinesthat no additional disinfection cycles remain to be completed. In otherwords, reprocessing method (480) will proceed to step (499) to terminatethe disinfection stage when reprocessing system (410) has performed thefill and purge disinfection cycle the predetermined “n” number of times.

While the disinfection stage of reprocessing method (480) is shown anddescribed above as being repeatable for a predetermined number “n” ofdisinfection cycles (i.e., a type of fill and purge cycle, as describedabove), each comprising step (490) through step (497), it will beappreciated that other stages of reprocessing method (480) may berepeated for a respective, predetermined number of fill and purge cyclesas well. For instance, the washing and rising stage of method (480)defined by step (482) through step (486) may be repeated for arespective predetermined number of cycles, each being a fill and purgecycle.

B. Medical Device Reprocessing Apparatus and Method Using ConcentratedDisinfectant

As previously mentioned, in some instances an endoscope (200) mayinclude an elevator channel with a cable or wire positioned therein,such as in a duodenoscope. The cable contained within an elevatorchannel of a duodenoscope may be in the form of a twisted cable havingvarious gaps and crevices capable of housing bioburdens, water,particles, and other substances therebetween. Further, due to thesurface tension of the twisted cable or wire, water and other particlesmay remain in the gaps and crevices even after a disinfectant isdelivered into the elevator channel. The remaining water or othersubstances contained within the elevator channel may tend to dilute anydisinfectant subsequently delivered into the elevator channel fordisinfection, thereby rendering the process of reducing the bioburdenlevel of the internal channels more difficult. Additionally, thepresence of the cable or wire within the elevator channel creates anadditional restriction as the cable or wire significantly limits thevolume of disinfectant that can flow through the elevator channel.

Ultimately, with an elevator channel having a small diameter and thepresence of a cable or wire contained therein, the challenge to reducethe bioburden level in the endoscope (200) significantly increases.Providing a reprocessing system and method similar to reprocessingsystem (410) and reprocessing method (480) described above, may bedesirable to adequately disinfect the internal channels of an endoscopethrough a recurring cleaning cycle. However, with the enhanceddifficulties in reprocessing elevator channels containing a cable orwire contained therein, it may be desirable for the reprocessing systemand method to utilize disinfectant concentrate during each cycle. Inthis instance, previously used disinfectant is not recycled through thereprocessing system to ensure the concentration of the disinfectant isrelatively high for each recurring cycle to sufficiently increase thebioburden reduction efficacy in the elevator channel of a duodenoscope.

Providing a methodical approach to disinfecting the inner components ofan endoscope may be beneficial to ensure the proper degree of bioburdenreduction is achieved in each instance. The following descriptionprovides various examples of a reprocessing system and method configuredto adequately disinfect the internal channels of an endoscope (200)through a recurring cleaning cycle using concentrated disinfectant foreach cycle. It should be understood that the reprocessing methoddescribed below may be readily incorporated into any of the variousreprocessing systems (2, 310, 310′, 410) and to any of the variousendoscopes (200) described above. Other suitable ways in which thebelow-described reprocessing method may be used will be apparent tothose of ordinary skill in the art in view of the teachings herein.

FIG. 8 shows a block schematic of an exemplary reprocessing system (510)including a disinfectant storage (511), a detergent storage (515), anair supply system (521), and a water supply (525). Except as otherwisedescribed below, reprocessing system (510), disinfectant storage (511),detergent storage (515), air supply system (521), and water reservoir(525) are configured and operable just like reprocessing system (2, 310,310′, 410), disinfectant storage (92, 360, 411), disinfectant storage(86, 415), air supply system (36, 421), and water supply (50, 425),respectively, described above. Internal channels (520) of an endoscope(500) are in fluid communication with disinfectant storage (411),detergent storage (515), air supply system (521) and water reservoir(525) via flush lines (544). Reprocessing system (510) is operable todeliver disinfectant solution (92), detergent solution (86), air andwater to internal channels (520) of endoscope (500) individually andsequentially. While only one endoscope (500) is shown as beingreprocessed in reprocessing system (510), it should be understood thatreprocessing system (510) may be capable of reprocessing more than oneendoscope (500) simultaneously and/or in a sequence.

Flush lines (544) include a flush valve (546) for each channel (520)operatively connected to reprocessing system (510). Flush valves (546)are positioned downstream of disinfectant storage (511), detergentstorage (515), air supply system (521), and water reservoir (525). Inthe present example, disinfectant storage (511) is in fluidcommunication with a disinfectant pump (512), a flow sensor (513) and acheck valve (514) in sequence, such that disinfectant pump (512) isconfigured to transfer disinfectant (92) from disinfectant storage (511)to flow sensor (513) and through check valve (514) via flush lines(544). In this instance, disinfectant solution (92) is a highconcentrate disinfectant or sterilant that is capable of providingadequate bioburden reduction within internal channels (520).

Flow sensor (513) is operable to monitor the flow of concentrateddisinfectant (92) delivered from disinfectant pump (512) to internalchannels (520) of endoscopes (500). Control system (20) of reprocessingsystem (510) is configured to execute a control algorithm (see FIG. 9)to open flush valve (546), which is in fluid connection with endoscope(500), and retrieve the data monitored by flow sensor (513). Controlsystem (20) is operable to terminate fluid communication betweendisinfectant pump (512) and endoscope (500) when the data indicates thatinternal channels (520) have received a sufficient amount ofdisinfectant (92) by closing flush valves (546).

Similarly, detergent storage (515) is in fluid communication with adetergent pump (516), a flow sensor (517) and a check valve (518) insequence, such that detergent pump (516) is configured to transferdetergent solution (86) to flow sensor (517) and through check valve(518) via flush lines (544). Flow sensor (517) is operable to monitorthe elapsed duration as detergent (86) is delivered from detergent pump(516) to internal channels (520) of endoscope (500). In other words,reprocessing system (510) is configured to terminate the fluidcommunication between detergent pump (516) and flush valves (546), byclosing flush valves (546), once the elapsed duration monitored by flowsensor (517) has met a predetermined time threshold for deliveringdetergent (86) to endoscope (500). Alternatively, or in conjunction,reprocessing system (510) is configured to cease operation of detergentpump (516) from pumping detergent (86) to internal channels (520). Ineach instance, reprocessing system (510) is configured to close flushvalves (546) when internal channels (520) have received a sufficientamount of detergent (86) therein, as sensed by flow sensor (517).

Air supply system (521) is in communication with an air pump (522), afilter (523) and a check valve (524). Air pump (522) is configured topush pressurized air from air supply system (521) through filter (523)and check valve (524), thereby delivering a stream of air into andthrough internal channels (520) of endoscope (500). Filter (523) isoperable to filter and remove microbes from the incoming air streamextracted from air supply system (521). In some illustrative examples,filter (523) comprises a HEPA microbe-removing filter. In some versions,reprocessing system (510) may exclude filter (523) in communication withair pump (522) and check valve (524). Water reservoir (525) is in fluidcommunication with a water pump (526), a flow sensor (527) and a checkvalve (528). Water pump (526) is configured to pump water from waterreservoir (525) to flow sensor (527) and through check valve (528) viaflush lines (544).

Reprocessing system (510) is operable to open flush valve (546) and tomeasure the quantity of water delivered from water pump (526) tointernal channels (520) of endoscope (500). Flow sensor (527) isoperable to monitor the quantity of water delivered to internal channels(520). In this instance, reprocessing system (510) is configured toclose flush valve (546) when internal channels (520) have received asufficient amount of water. Reprocessing system (510) further includesbasin (14 a) in fluid communication with internal channels (520) ofendoscope (500) via flush lines (544). Basin (14 a) is operable toreceive any fluids or air released from internal channels (520). Aspreviously mentioned, although not shown, it should be understood thatreprocessing system (510) may include a single pump assembly such thatthe same pump is configured to deliver detergent (86), water,pressurized air, and concentrated detergent (92). In this instance,reprocessing system (510) is configured to selectively open and close aseries of flush valves (546) to individually deliver the varioussubstances with the single pump assembly.

FIG. 9 shows a flow diagram illustrating steps of an exemplaryreprocessing method (580) that may be used by reprocessing system (510)to perform a predetermined number of fill and purge disinfection cyclesof internal channels (520) of endoscope (500). At step (582),reprocessing system (510) initiates detergent pump (512) to deliverdetergent solution (86) to endoscope (500) via flush lines (544).Reprocessing system (510) is configured to deliver detergent (86)through internal channels (520) at a predetermined flow rate. At step(584), as detergent (86) is transferred from detergent storage (515) toendoscope (500), flow sensor (517) measures an elapsed duration of flowas detergent pump (516) actively pumps detergent (86) toward internalchannels (520). Reprocessing system (510) ceases operation of detergentpump (516) when the elapsed flow time equals a predetermined timethreshold for detergent delivery. Subsequently, at step (586),reprocessing system (510) initiates water pump (526) to deliver water toendoscope (500) via flush lines (544) and through internal channels(520), to thereby rinse any remaining detergent (86) out from internalchannels (520) and into basin (14 a). In this instance, flow sensor(527) measures an elapsed duration of flow as water pump (526) pumpswater into internal channel (520). Reprocessing system (510) ceasesoperation of water pump (526) when the elapsed flow time equals apredetermined time threshold for rinsing.

At step (588), reprocessing system (510) initiates air pump (522) tosend pressurized air from air supply system (521) through filter (523)and into endoscope (500). The stream of air passes through internalchannels (520) thereby purging internal channels (520) of any residualdetergent (86) or water contained therein. Air pump (522) continues toflow pressurized air through internal channels (520) until a specifiedflow duration elapses signaling for reprocessing system (510) to ceaseoperation of air pump (522). Reprocessing system (510) terminates airpump (522) once the elapsed flow time has reached a predetermined timethreshold for air purging. At step (590), with air pump (522) inactive,disinfectant pump (512) beings to pump high concentrate disinfectant(92) to internal channels (520) of endoscope (500) simultaneously.Reprocessing system (510) monitors the volume of disinfectant (92)transferred from disinfectant storage (511) to endoscopes (500) andceases operation of disinfectant pump (512) when the volume deliveredsubstantially equals a predetermined threshold, as seen at step (592).Reprocessing system (510) closes all flush valves (546) simultaneouswith the deactivation of disinfectant pump (512). In this instance, asseen at step (594), reprocessing system (510) evaluates whether internalchannels (520) of endoscope (500) has stored the high concentratedisinfectant (92) for a minimum dwell time. As merely an illustrativeexample, the predetermined dwell time can range between approximately 10seconds to 30 seconds. Although not shown, it should be understood thatin some versions reprocessing system (510) may forego holding the highconcentrate disinfectant (92) in the internal channels (520) for theminimum dwell time. Instead, flush valves (546) may remain open afterthe deactivation of disinfectant pump (512) and reprocessing system(510) may initiate water pump (526) and air pump (522), respectively insequential order as described above.

At step (596), once reprocessing system (510) has determined thatinternal channels (520) have maintained disinfectant (92) for theminimum dwell time, flush valves (546) are reopened and air pump (522)is reactivated. In this instance, pressurized air is flowed throughinternal channels (520) to thereby purge disinfectant (92) fromendoscope (500). The flow rate of disinfectant (92) being released fromwithin internal channels (520) into basin (14 a) is increased due to theflow of pressurized air, thereby enhancing the bioburden removal. Atstep (598), with disinfectant (92) released into basin (14 a) andcontained therein, reprocessing system (510) determines whether theabove described fill and purge disinfection cycle has been performed apredetermined “n” number of times. Upon the determination byreprocessing system (510) that additional fill and purge disinfectioncycles remain to be completed, reprocessing system (510) will continueto perform step (590) through step (598) until reprocessing system (510)determines that no additional fill and purge disinfection cycles remainto be completed. In other words, reprocessing method (580) will proceedto step (599) to terminate the disinfection state when reprocessingsystem (510) has performed the fill and purge disinfection cycle thepredetermined “n” number of times.

V. Exemplary Methods of Filing and Purging Internal Channels of aMedical Device Based on Sensor Feedback

As described above, forcibly directing various liquids such asdetergents and disinfectants through the internal channels of a medicaldevice is generally effective to lower the bioburden level within thechannels. In particular, the liquids exert shear stresses on the innerwalls of the channels that have destructive effects on local bioburden.When liquid enters an empty channel, the liquid flow rate of the liquidis high, and the associated shear stress exerted on the channel walls bythe liquid is proportionally high. As the channel approaches a filledstate, backpressure within the channel increases and causes the liquidflow rate and the associated shear stress to decrease. When water orpressurized air is injected into the filled channel to purge the liquid,the liquid flow rate and associated shear stress increases as the volumeof the liquid within the channel decreases. Thus, to maximize shearstress and resulting bioburden reduction within a channel duringreprocessing retreatment, it may be desirable to complete each fill andpurge cycle as quickly as possible. The exemplary elements and methodsdescribed below promote optimal bioburden reduction efficacy within theinternal channels of a medical device by controlling filling and purgingof the channels to maximize shear stresses exerted on the channel walls.

A. Filling and Purging Internal Channels of Device Based on Feedbackfrom Flow Rate Sensor

FIG. 10 shows a proximal portion of endoscope (200) connected to aportion of another exemplary reprocessing system (700). Reprocessingsystem (700) is similar to reprocessing systems (2, 310, 410, 510)described above except as otherwise described below. Reprocessing system(700) of the present example includes a multi-way flush valve unit (702)that may be in the form of a three-way valve or a pair of two-wayvalves, for example as described below in connection with reprocessingsystems (1000, 1100) of FIGS. 15 and 16. A first inlet of flush valveunit (702) is coupled to a liquid fill line (704), a second inlet offlush valve unit (702) is coupled to an air purge line (705), and anoutlet of flush valve unit (702) is coupled to a flush line (706). Whileflush line (706) is shown fluidly coupled with biopsy channel (218) viaconnection (232) in the present example, it will be appreciated thatflush line (706) may be fluidly coupled with various other internalchannels (210, 212, 213, 214, 217) of endoscope (200) in other examples.Furthermore, reprocessing system (700) may include a plurality of flushlines (706) and respective multi-way flush valve units (702), each beingconfigured to fluidly couple with a respective internal channel (210,212, 213, 214, 217, 218) of endoscope (200).

Liquid fill line (704) of reprocessing system (700) is configured todeliver a fill liquid, such as detergent or disinfectant, to flush valveunit (702), which is operable to then direct the fill liquid to internalchannel (210, 212, 213, 214, 217, 218) via flush line (706). Air purgeline (705) is configured to deliver compressed air to flush valve unit(702), which is operable to then direct the compressed air to internalchannel (210, 212, 213, 214, 217, 218) via flush line (706). In someversions, flush valve unit (702) may include a third inlet coupled to aliquid rinse line (not shown) configured to deliver a liquid, such aswater, to flush valve unit (702), which would then direct the liquidthrough flush line (706) for rinsing internal channel (210, 212, 213,214, 217, 218).

Flush valve unit (702) is similar to flush valves (446) described abovein that flush valve unit (702) is selectively operable by a controller(not shown), which may be similar to controller (20) of system (2), todirect fluids from the various fluid sources (not shown) of reprocessingsystem (700) to an internal channel (210, 212, 213, 214, 217, 218) ofendoscope (200). For instance, the controller may selectively operateflush valve unit (702) to direct one or more liquids such as detergent,water, or disinfectant through flush line (706) and into internalchannel (210, 212, 213, 214, 217, 218). The controller may furtheroperate flush valve (702) to direct compressed air from air purge line(705), through flush line (706), and into internal channel (210, 212,213, 214, 217, 218). Accordingly, “fluid” as used herein encompassesboth liquids and gasses.

As shown in FIG. 10, reprocessing system (700) further includes a flowrate sensor (708) coupled with flush line (706) downstream of flushvalve unit (702). Flow rate sensor (708) may be arranged directly withinflush line (706), or otherwise in fluid communication with flush line(706). In other versions, flow rate sensor (708) may be coupled withliquid fill line (704) upstream of flush valve unit (702). Such aconfiguration may be desirable in some instances to avoid exposing flowrate sensor (708) to compressed air directed through flush line (706)from air purge line (705). As described in greater detail below, flowrate sensor (708) is operable to measure a flow rate of a liquid beingdirected into internal channel (210, 212, 213, 214, 217, 218), andcommunicate the measured flow rate to the system controller.

FIG. 13 shows a flow diagram illustrating steps of an exemplary method(710) for using reprocessing system (700) described above to reprocessan internal channel of a medical device, such as any one or more ofinternal channels (210, 212, 213, 214, 217, 218) of endoscope (200). Asdescribed below, liquid flow rate data provided by flow rate sensor(708) is referenced by the system controller to automatically determinean optimum fill time and an optimum purge time for the respectiveinternal channel (210, 212, 213, 214, 217, 218) so as to maximize shearstress and resulting bioburden reduction efficacy within the channel(210, 212, 213, 214, 217, 218) during a fill a purge cycle.

In versions of reprocessing system (700) that include multiple flushlines (702) each having a respective flow rate sensor (708), flow ratesensors (708) may communicate with the system controller independentlysuch that the controller may automatically determine an optimum filltime and purge time for each of the respective internal channels (210,212, 213, 214, 217, 218). This may be particularly advantageous forapplications in which internal channels (210, 212, 213, 214, 217, 218)are formed with different diameters such that channels (210, 212, 213,214, 217, 218) accept different volumes of liquids during the fill stepof a fill and purge cycle.

As shown in FIG. 13, method (710) includes an initial step (712) ofactivating a liquid pump of reprocessing system (700) and actuatingflush valve unit (702) to deliver a liquid to through flush line (706)and into internal channel (210, 212, 213, 214, 217, 218). The liquid maybe in the form of water, detergent, disinfectant/sterilant, or variousother suitable reprocessing liquids readily apparent to those ofordinary skill in the art in view of the teachings herein. Additionally,the liquid pump may be similar to any of the liquid pumps ofreprocessing systems (2, 310, 410, 510, 610) described above. At step(714), the reprocessing system controller begins monitoring the liquidflow rate of the liquid as it passes through flush line (706), oranother fluid line with which flow rate sensor (708) is coupled, viameasurements provided by flow rate sensor (708). Throughout the channelfiling process, the controller assesses at step (716) whether themeasured liquid flow rate within flush line (706) has decreased to thepoint of stabilizing at a steady state, thereby indicating that internalchannel (210, 212, 213, 214, 217, 218) has completely filled withliquid. Specifically, the controller compares the measured flow ratedetected by flow rate sensor (708) to a predetermined flow rateassociated with the liquid and channel (210, 212, 213, 214, 217, 218) ina filled state.

It will be appreciated that the flow rate measured within flush line(706) by flow rate sensor (708) may start at a first flow rate anddecrease as channel (210, 212, 213, 214, 217, 218) fills with liquid.When the channel (210, 212, 213, 214, 217, 218) has filled, the flowrate within flush line (706) stabilizes at a decreased second flow rate.For instance, in one example the liquid flow rate may start atapproximately 100 mL per minute upon initial entry of liquid intointernal channel (210, 212, 213, 214, 217, 218) when the flush valveunit (702) is initially actuated, and then settle at a steady state flowrate of approximately 50 mL per minute after approximately 2 seconds offill time measured from the actuation of flush valve unit (702). If thecontroller determines that the liquid flow rate has not yet reached asteady state flow, thus indicating that internal channel (210, 212, 213,214, 217, 218) has not yet completely filled with liquid, the controllercontinues to power the liquid pump to deliver liquid to internal channel(210, 212, 213, 214, 217, 218) by repeating steps (712)-(716). Once thecontroller identifies at step (716) that the liquid within internalchannel (210, 212, 213, 214, 217, 218) has reached a steady state flow,the controller determines that internal channel (210, 212, 213, 214,217, 218) has completely filled. At step (718), the controller recordsthe amount of time that the liquid pump has been running since theinitial actuation of flush valve unit (702) to fill channel (210, 212,213, 214, 217, 218) with liquid (“Fill Time”). Simultaneously, thecontroller may actuate flush valve unit (702), and optionally deactivatethe liquid pump, to cease channel filling and commence channel purging,as described below.

The system controller initiates purging of channel (210, 212, 213, 214,217, 218) at step (720) by activating an air pump, which may be similarto any of the air pumps of reprocessing systems (2, 310, 410, 510, 610)described above, and actuating flush valve unit (702) to deliverpressurized air through flush line (706) and into internal channel (210,212, 213, 214, 217, 218). Meanwhile, the system controller continues tomonitor the liquid flow rate within flush line (706) at step (722) viameasurements provided by flow rate sensor (708). Upon detecting at step(724) that the measured liquid flow rate has decreased relative to astarting liquid flow rate measured at the initiation of purging step(720) (e.g., the steady state flow rate discussed above), the controllerdetermines that the purging of channel (210, 212, 213, 214, 217, 218) iscomplete. In that regard, those skilled in the art will appreciate thatthe pressurized air passing through flush line (706) is much less densethan the liquid, such that flow rate sensor (708) will register a dropin liquid flow rate when channel (210, 212, 213, 214, 217, 218) ispurged to the point that predominantly only air is passing by flow ratesensor (708) within flush line (706). In some versions, the controllermay determine that purging of channel (210, 212, 213, 214, 217, 218) iscomplete once the measured flow rate is less than or equal to apredetermined flow rate that corresponds to an adequately purged stateof channel (210, 212, 213, 214, 217, 218). Upon determining thatinternal channel (210, 212, 213, 214, 217, 218) has been adequatelypurged of liquid, the system controller ceases purging by actuatingflush valve unit (702) and optionally deactivating the air pump.Simultaneously, the controller proceeds to step (726) to record theamount of time that the air pump ran since flush valve unit (702) wasactuated to initiate purging of channel (210, 212, 213, 214, 217, 218)with pressurized air (“Purge Time”).

At step (728), the controller assesses whether a predetermined quantity(“n”) of fill and purge cycles of internal channel (210, 212, 213, 214,217, 218) has been completed. If the predetermined quantity has not beencompleted, the system (700) proceeds to step (730) and actuates flushvalve unit (702), and optionally also reactivates the liquid pump ifpreviously deactivated, to deliver liquid through flush line (706) andto channel (210, 212, 213, 214, 217, 218) for the Fill Time. Immediatelyupon expiration of the Fill Time in step (730), the controller actuatesflush valve unit (702) to cease liquid fill and commence pressurized airpurge of internal channel (210, 212, 213, 214, 217, 218) at step (732).This step may optionally include deactivating the liquid pump andreactivating the air pump in some instances. During step (732), system(700) directs pressurized air into internal channel (210, 212, 213, 214,217, 218) for the Purge Time to purge the liquid from channel (210, 212,213, 214, 217, 218). In some versions, system (700) may instead directpressurized air into channel (210, 212, 213, 214, 217, 218) for the FillTime.

Immediately upon completing step (732), or while completing step (732),the controller repeats step (728) to determine whether the predeterminedquantity of fill and purge cycles has been completed. If thepredetermined quantity has still not yet been completed, the controllerrepeats steps (730), (732), and (728) sequentially as many times asnecessary until the predetermined quantity of cycles is completed. Then,the controller proceeds to step (734) and terminates the filling andpurging process.

As described above, method (710) may be performed independently for eachof the internal channels of a medical device, such as each of internalchannels (210, 212, 213, 214, 217, 218) of endoscope (200).

B. Filling and Purging Internal Channels of Device Based on Feedbackfrom Pressure Sensor

FIG. 11 shows a proximal portion of endoscope (200) connected to aportion of another exemplary reprocessing system (800). Reprocessingsystem (800) is similar to reprocessing system (700) described aboveexcept as otherwise described below. Like reprocessing system (700),reprocessing system (800) includes a multi-way flush valve unit (802)having a first inlet coupled to a liquid fill line (804), a second inletcoupled to an air purge line (705), and an outlet coupled to a flushline (806). While flush line (806) is shown fluidly coupled with biopsychannel (218) via connection (232) in the present example, it will beappreciated that flush line (806) may be fluidly coupled with variousother internal channels (210, 212, 213, 214, 217) of endoscope (200) inother examples. Furthermore, reprocessing system (800) may include aplurality of flush lines (806) and respective multi-way flush valveunits (802), each being configured to fluidly couple with a respectiveinternal channel (210, 212, 213, 214, 217, 218) of endoscope (200).

Reprocessing system (800) includes a pressure sensor (808) in place offlow rate sensor (708) of reprocessing system (700). In the presentversion, pressure sensor (808) is coupled with flush line (806)downstream of flush valve unit (802). In other versions, pressure sensor(808) may be coupled with liquid fill line (804) upstream of flush valveunit (802). As described in greater detail below, pressure sensor (808)is operable to measure a pressure within flush line (806) duringoperation of reprocessing system (800) and communicate the measuredpressure to a controller of system (800).

FIG. 14 shows a flow diagram illustrating steps of an exemplary method(810) for using reprocessing system (800) described above to reprocessan internal channel of a medical device, such as any one or more ofinternal channels (210, 212, 213, 214, 217, 218) of endoscope (200). Asdescribed below, pressure data provided by pressure sensor (808) isreferenced by the system controller to automatically determine anoptimum fill time and an optimum purge time for the respective internalchannel (210, 212, 213, 214, 217, 218) so as to maximize shear stressand resulting bioburden reduction efficacy within the channel (210, 212,213, 214, 217, 218) during a fill a purge cycle.

In versions of reprocessing system (800) that include multiple flushlines (802) each having a respective flow rate sensor (808), flow ratesensors (808) may communicate with the system controller independentlysuch that the controller may automatically determine an optimum filltime and purge time for each of the respective internal channels (210,212, 213, 214, 217, 218). This may be particularly advantageous forapplications in which internal channels (210, 212, 213, 214, 217, 218)are formed with different diameters such that channels (210, 212, 213,214, 217, 218) accept different volumes of liquids during the fill stepof a fill and purge cycle.

As shown in FIG. 14, method (810) includes an initial step (812) ofactivating a liquid pump of reprocessing system (800) and actuatingflush valve unit (802) to deliver a liquid through flush line (806) andinto internal channel (210, 212, 213, 214, 217, 218). The liquid may bein the form of water, detergent, disinfectant/sterilant, or variousother suitable reprocessing liquids readily apparent to those ofordinary skill in the art in view of the teachings herein. Additionally,the liquid pump may be similar to any of the liquid pumps ofreprocessing systems (2, 310, 410, 510, 610) described above. At step(814), the reprocessing system controller begins monitoring the internalpressure within flush line (806), or another fluid line with whichpressure sensor (808) is coupled, via measurements provided by pressuresensor (808). Throughout the channel filing process, the controllercontinually assesses whether the measured pressure within flush line(806) has increased to the point of stabilizing at a steady statepressure, thereby indicating that channel (210, 212, 213, 214, 217,218)has completely filled with liquid. Specifically, the controller comparesthe measured pressure detected by pressure sensor (808) to apredetermined pressure associated with the liquid and channel (210, 212,213, 214, 217, 218) in a filled state.

In that regard, it will be appreciated by those skilled in the art thatthe pressure measured by pressure sensor (808) within flush line (806)may increase as channel (210, 212, 213, 214, 217, 218) fills, andeventually stabilize at a maximum pressure once channel (210, 212, 213,214, 217, 218) is completely filled. If the controller determines thatthe pressure within flush line (806) has not yet stabilized at a maximumpressure, thus indicating that internal channel (210, 212, 213, 214,217, 218) has not yet completely filled with liquid, the controllercontinues to power the liquid pump to deliver liquid to internal channel(210, 212, 213, 214, 217, 218) by repeating steps (812)-(816). Once thecontroller identifies that the pressure within flush line (806) hasstabilized at a maximum pressure, the controller determines thatinternal channel (218) is completely filled. At step (818), thecontroller records the amount of time that the liquid pump has beenrunning since the initial actuation of flush valve unit (802) to fillchannel (210, 212, 213, 214, 217, 218) with liquid (“Fill Time”).Simultaneously, the controller may actuate flush valve unit (802), andoptionally deactivate the liquid pump, to cease channel filling andcommence channel purging, as described below.

The system controller initiates purging of channel (210, 212, 213, 214,217, 218) at step (820) by activating an air pump, which may be similarto any of air pumps (38, 110, 422, 522) described above, and actuatingflush valve unit (802) to deliver pressurized air through flush line(806) and into channel (210, 212, 213, 214, 217, 218). Meanwhile, thesystem controller continues to monitor the pressure within flush line(806) at step (822) via measurements provided by pressure sensor (808).Upon detecting at step (824) that the measured pressure has decreasedand stabilized at a new pressure, the controller determines that thepurging of channel (210, 212, 213, 214, 217, 218) is complete.

As described above, it will be appreciated by those skilled in the artthat the pressurized air passing through channel (218) is much lessdense than the liquid, such that the pressure sensor (808) will registera drop in pressure within flush line (806) when channel (210, 212, 213,214, 217, 218) is purged to the point that no substantially no liquidremains within channel (210, 212, 213, 214, 217, 218). In some versions,the controller may determine that purging of channel (210, 212, 213,214, 217, 218) is complete once the measured pressure is less than orequal to a predetermined pressure that corresponds to an adequatelypurged state. Upon determining that internal channel (210, 212, 213,214, 217, 218) has been adequately purged of liquid, the systemcontroller ceases purging by actuating flush valve unit (802) andoptionally deactivating the air pump. Simultaneously, the controllerproceeds to step (826) to record the amount of time that the air pumpran since flush valve unit (802) was actuated to initiate purging ofchannel (210, 212, 213, 214, 217, 218) with pressurized air (“PurgeTime”).

At step (828), the controller assesses whether a predetermined quantity(“n”) of fill and purge cycles of internal channel (210, 212, 213, 214,217, 218) has been completed. If the predetermined quantity has not beencompleted, the system (800) proceeds to step (830) and actuates flushvalve unit (802), and optionally also reactivates the liquid pump ifpreviously deactivated, to deliver liquid through flush line (806) andto channel (210, 212, 213, 214, 217, 218) for the Fill Time. Immediatelyupon expiration of the Fill Time in step (830), the controller actuatesflush valve unit (802) to cease liquid fill and commence pressurized airpurge of internal channel (210, 212, 213, 214, 217, 218). This step mayoptionally include deactivating the liquid pump and reactivating the airpump in some instances. During step (832) system (800) directspressurized air into internal channel (210, 212, 213, 214, 217, 218) forthe Purge Time to purge the liquid from channel (210, 212, 213, 214,217, 218). In some version, system (800) may instead direct pressurizedair into channel (210, 212, 213, 214, 217, 218) for the Fill Time.

Immediately upon completing step (832), or while completing step (832),the controller repeats step (828) to determine whether the predeterminedquantity of fill and purge cycles has been completed. If thepredetermined quantity has still not yet been completed, the controllerrepeats steps (830), (832), and (828) sequentially as many times asnecessary until the predetermined quantity (“n”) of cycles is completed.Then, the controller proceeds to step (834) and terminates the fillingand purging process.

As described above, method (810) may be performed independently for eachof the internal channels of a medical device, such as each of internalchannels (210, 212, 213, 214, 217, 218) of endoscope (200).

C. Filling and Purging Internal Channels of Device Based on Feedbackfrom Flow Rate Sensor and Pressure Sensor

FIG. 12 shows a proximal portion of endoscope (200) connected to aportion of another exemplary reprocessing system (900). Reprocessingsystem (900) is similar to reprocessing systems (700, 800) describedabove except as otherwise described below. Like reprocessing systems(700, 800), reprocessing system (900) of the present example includes amulti-way flush valve unit (902) having a first inlet coupled to aliquid fill line (904), a second inlet coupled to an air purge line(905), and an outlet coupled to a flush line (906). While flush line(906) is shown fluidly coupled with biopsy channel (218) via connection(232) in the present example, it will be appreciated that flush line(906) may be fluidly coupled with various other internal channels (210,212, 213, 214, 217) of endoscope (200) in other examples. Furthermore,reprocessing system (900) may include a plurality of flush lines (906)and respective multi-way flush valve units (902), each being configuredto fluidly couple with a respective internal channel (210, 212, 213,214, 217, 218) of endoscope (200).

Reprocessing system (900) further includes a pressure sensor (908) and aflow rate sensor (910). In the present version, pressure sensor (908)and flow rate sensor (910) are coupled with flush line (906) downstreamof flush valve unit (902). In other versions, flow rate sensor (910) maybe coupled with liquid fill line (904) upstream of flush valve unit(902), for instance to avoid exposing flow rate sensor (910) tocompressed air directed through flush line (906) from air purge line(905). Pressure sensor (908) is generally similar to pressure sensor(808) of reprocessing system (800), and flow rate sensor (910) isgenerally similar to flow rate sensor (708) of reprocessing system(700). In particular, pressure sensor (908) is operable to measure andcommunicate with a controller (not shown) of system (900) regarding apressure within flush line (906), and flow rate sensor (910) is operableto measure and communicate with the controller regarding a flow rate ofliquid passing through flush line (906).

The controller of reprocessing system (900) may monitor both sets ofsensor data, provided by pressure sensor (908) and flow rate sensor(910), to automatically determine a precise Fill Time and Purge Time fora particular internal channel (210, 212, 213, 214, 217, 218) suitable toyield maximum shear stresses inside the channel (210, 212, 213, 214,217, 218), and thus enhanced bioburden reduction efficacy. For instance,in one exemplary version, the controller may determine an optimum FillTime for a given internal channel (210, 212, 213, 214, 217, 218) basedon liquid flow rate data provided by flow rate sensor (910), and anoptimum Purge Time for the channel (210, 212, 213, 214, 217, 218) basedon pressure data provided by pressure sensor (908). In another exemplaryversion, the controller may determine each of an optimum Fill Time andan optimum Purge Time for a given channel (210, 212, 213, 214, 217, 218)using a respective algorithm that relies on input data provided by bothflow rate sensor (910) and pressure sensor (908). In versions in whichreprocessing system (900) includes multiple flush valve units (902) andrespective flush lines (906) and sensors (908, 910), the systemcontroller may determine a unique Fill Time and a unique Purge Time foreach internal channel (210, 212, 213, 214, 217, 218) of endoscope (200),independently, based on data provided by the respective pair of sensors(908, 910) arranged in fluid communication with the internal channel(210, 212, 213, 214, 217, 218).

VI. Treating Multiple Channels of a Device Simultaneously andAsynchronously Via Multi-Way Valve Units

As described above, optimizing the bioburden reduction efficacy of aretreatment process for the internal channel of a medical device may beachieved by maximizing the shear stress exerted on the inner walls ofthe channel by the retreatment liquid. Maximum shear stress may beachieved by filling and purging the channel as quickly as possible. Insome instances, the medical device may have multiple internal channelsthat require treatment, and it may be desirable to complete the fill andpurge cycles of those channels simultaneously.

The exemplary systems and methods described below enable filling andpurging of multiple internal channels of a device simultaneously, whilecontrolling the filing and purging of each channel independently so asto achieve maximum shear stress and resulting bioburden reduction withinthe channel.

A. Exemplary Reprocessing System Having 3-Way Valve Units

FIG. 15 shows a schematic diagram of an exemplary reprocessing system(1000) operable to decontaminate medical devices having internal lumensor channels, such as an endoscope. System (1000) is similar toreprocessing systems (2, 310, 410, 510, 610) described above, except asotherwise described below. As shown, reprocessing system (1000)generally includes a liquid inlet line (1002) comprising a liquid pump(1004). System (1000) further includes an air inlet line (1006)comprising an air filter (1008), an air pump (1010), a check valve(1012), and an air reservoir (1014), connected in series. The componentsof liquid inlet line (1002) and air inlet line (1004) may be similar instructure and function to any one or more of the correspondingcomponents of reprocessing systems (2, 310, 410, 510, 610) describedabove. Moreover, while only one liquid pump (1004) and one air pump(1010) are shown in the present version, a plurality of one or bothtypes of pumps (1004, 1010) may be provided in other versions.

Reprocessing system (1000) further includes a plurality of multi-wayvalve units (1016 a-1016 n), each of which includes a liquid inlet (1018a-1018 n) that fluidly communicates with liquid inlet line (1002), anair inlet (1020 a-1020 n) that fluidly communicates with air inlet line(1006), and an outlet (1022 a-1022 n) configured to fluidly communicatewith a respective internal channel (1032 a-1032 n) of a medical device(1030). In the present example, multi-way valve units (1016 a-1016 n)are shown in the form of 3-way valves. As indicated schematically inFIG. 15, reprocessing system (1000) may include any suitable quantity of3-way valve units (1016 a-1016 n) to accommodate any correspondingquantity of internal channels (1032 a-1032 n) of medical device (1030).Medical device (1030) may be in the form of an endoscope, such asendoscope (200) described above.

Valve unit outlets (1022 a-1022 n) of reprocessing system (1000) arefluidly isolated from one another such that each valve unit (1016 a-1016n) is operable to deliver liquid and pressurized air to its respectivedevice channel (1032 a-1032 n) independently of every other valve unit(1016 a-1016 n). One or more actuators (not shown) may be coupled withthe moving components of each valve unit (1016 a-1016 n) to selectivelytransition the liquid inlet (1018 a-1018 n), air inlet (1020 a-1020 n),and/or outlet (1022 a-1022 n) of each valve unit (1016 a-1016 n) betweenrespective open and closed states. Such actuators may communicatedirectly with a controller (1024) of reprocessing system (1000), whichmay be similar to controller (20) of reprocessing system (2) describedabove, for example. Controller (1024) may be configured to drive thevalve actuators to selectively control each valve unit (1016 a-1016 n)independently to deliver liquid and pressurized air to the respectiveinternal channel (1032 a-1032 n) of medical device (1030) for selecteddurations of time. In some versions, the selected durations of time maybe determined using the exemplary methods described above in connectionwith FIGS. 10-14.

In an exemplary use of reprocessing system (1000), system controller(1024) may command the valve actuators to place each of valve units(1016 a-1016 n) in an initial channel-filling state in which liquidinlets (1018 a-1018 n) are open, air inlets (1020 a-1020 n) are closed,and outlets (1022 a-1022 n) are open. Controller (1024) may thenactivate liquid pump (1004) to deliver liquid to internal channels (1032a-1032 n) of medical device (1030) via liquid inlets (1018 a-1018 n) andoutlets (1022 a-1022 n) of the respective valve units (1016 a-1016 n).Controller (1024) may control each valve unit (1016 a-1016 n)independently to deliver liquid to the respective device channel (1032a-1032 n) for a respective duration of time. For instance, after a firstduration of time following the initiation of filling first channel (1032a) has elapsed, controller (1024) may close first liquid inlet (1018 a)and open first air inlet (1020 a) of first valve unit (1016 a). Shortlythereafter, when a second duration of time following the initiation offilling second channel (1032 b) has elapsed, controller (1024) may closesecond liquid inlet (1018 b) and open second air inlet (1020 b) ofsecond valve unit (1016 b). Shortly thereafter, when a third duration oftime following the initiation of filling third channel (1032 c) haselapsed, controller (1024) may close third liquid inlet (1018 c) andopen third air inlet (1020 c) of third valve unit (1016 c). This processmay be extrapolated out for device channel (1032 n) and correspondingvalve unit (1016 n). In some instances, each of device channels (1032a-1032 n) may be filled for a respective unique duration of time, suchthat two or more of these durations overlap with one another.

Immediately upon or before opening first air inlet (1020 a) of firstvalve unit (1016 a), the controller may activate air pump (1010) todeliver pressurized air to first channel (1032 a) of medical device(1030) for purging the liquid from first channel (1032 a). Controller(1024) may keep air pump (1010) activated such that when second airinlet (1020 b) of second valve unit (1016 b) and third air inlet (1020c) of third valve unit (1016 c) subsequently open, second and thirdvalve units (1016 b, 1016 c) may immediately begin directing pressurizedair into second and third device channels (1032 b, 1032 c) for purging.After a fourth duration of time following the initiation of purgingfirst channel (1032 a) elapses, controller (1024) may close first airinlet (1020 a) of first valve unit (1016 a). Similarly, after a fifthduration of time following the initiation of purging second channel(1032 b) elapses, controller (1024) may close second air inlet (1020 b)of second valve unit (1016 b). Similarly, after a sixth duration of timefollowing the initiation of purging third channel (1032 c) elapses,controller (1024) may close third air inlet (1020 c) of third valve unit(1016 c). This process may be extrapolated out for device channel (1032n) and corresponding valve unit (1016 n). In some versions, theabove-described durations of time for filling and purging each channel(1032 a-1032 n) of medical device (1030) may be predetermined. In otherversions, the fill and purge time durations for each channel (1032a-1032 n) may be determined in real-time based on feedback provided byone or more sensors arranged within the channel (1032 a-1032 n), such asflow rate sensor (708, 910) and/or pressure sensor (808, 908) describedabove.

Immediately upon or before closing the air inlet (1020 a-1020 n) of avalve unit (1016 a-1016 n), controller (1024) may make an independentdetermination for the respective device channel (1032 a-1032 n) ofwhether an additional purge and fill cycle for the channel (1032 a-1032n) is required in order to complete a predetermined quantity of cycles.For instance, controller (1024) may determine for first channel (1032 a)that an additional cycle is required, and independently determine forsecond and third channels (1032 b, 1032 c) that no additional cycles arerequired. In such case, controller (1024) may close liquid and airinlets (1018 b, 1020 b, 1018 c, 1020 c) and/or outlets (1022 b, 1022 c)of second and third valve units (1016 b, 1016 c) to terminatereprocessing for second and third channels (1032 b, 1032 c), and maysimultaneously control first valve unit (1016 a) in the manner describedabove to perform an additional fill and purge cycle for first channel(1032 a).

As described above, reprocessing system (1000) is operable to treatmultiple internal channels (1032 a-1032 n) of a medical device (1030)simultaneously. Furthermore, system (1000) is configured to apply aunique fill time and a unique purge time for each channel (1032 a-1032n), independently of the other channels (1032 a-1032 n), such that thetreatment of two or more of channels (1032 a-1032 n) may be performedasynchronously. Moreover, the unique fill time and the unique purge timeapplied for each internal channel (1032 a-1032 n) may account for aunique inner diameter of the channel (1032 a-1032 n) relative to one ormore of the remaining channels (1032 a-1032 n). Accordingly, andadvantageously, system (1000) may provide an effective bioburdenreduction treatment for each internal channel (1032 a-1032 n) of device(1030) regardless of size differences among channels (1032 a-1032 n),while completing treatment for device (1030) in a time efficient manner.

B. Exemplary Reprocessing System Having 2-Way Valve Units

FIG. 16 shows another exemplary reprocessing system (1100) operable totreat multiple channels of a medical device simultaneously andasynchronously so as to provide a tailored bioburden reduction treatmentfor each internal channel, independently. Reprocessing system (1100) issimilar to reprocessing system (1000) described above, except asotherwise described below. Similar to reprocessing system (1000),reprocessing system (1100) includes a liquid inlet line (1102)comprising a liquid pump (1104), and an air inlet line (1106) comprisingan air filter (1108), an air pump (1110), a check valve (1112), and anair reservoir (1114). System (1100) further includes a plurality ofmulti-way valve units (1116 a-1116 n) operable to deliver liquid andpressurized air to internal channels (1032 a-1032 n) of medical device(1030), as described below.

Unlike valve units (1016 a-1016 n) of reprocessing system (1000), eachvalve unit (1116 a-1116 n) of reprocessing system (1100) comprises afirst 2-way valve (1118 a-1118 n) (or “liquid inlet valve”) and a second2-way valve (1120 a-1120 n) (or “air inlet valve”) that cooperate withone another in the manner generally described below. Liquid inlet valves(1118 a-1118 n) define respective liquid inlets for valve units (1116a-1116 n) that fluidly communicate with liquid inlet line (1102). Airinlet valves (1120 a-1120 n) define respective air inlets for valveunits (1116 a-1116 n) that fluidly communicate with air inlet line(1106). The liquid inlet valve (1118 a-1118 n) and corresponding airinlet valve (1120 a-1120 n) of each valve unit (1116 a-1116 n) feed intoa common valve unit outlet (1122 a-1122 n). Each valve unit outlet (1122a-1122 n) fluidly communicates with a respective internal channel (1032a-1032 n) of medical device (1030), and is fluidly isolated from outlets(1122 a-1122 n) of the remaining valve units (1116 a-1116 n).

Reprocessing system (1100) further includes a controller (1124) operableto control actuation of the movable components of each valve unit (1116a-1116 n) independently of the other valve units (1116 a-1116 n). Morespecifically, controller (1124) is operable to control each of theliquid inlet valves (1118 a-1118 n) independently, and each of the airinlet valves (1120 a-1120 n) independently. In use, controller (1124)may selectively control the opening and closing of each inlet valve(1118 a-1118 n, 1120 a-1120 n) to provide the corresponding internalchannel (1032 a-1032 n) of medical device (1030) with a tailored degreeof filling and a tailored degree of purging. For instance, controller(1124) may maintain each of the liquid inlet valves (1118 a-1118 n) inan open state for a respective unique fill time to fill a respectiveinternal channel (1032 a-1032 n) of medical device (1030) with liquid.Once a channel (1032 a-1032 n) has filled, controller (1124) may thenclose the corresponding liquid inlet valve (1118 a-1118 n), and thenopen and maintain the corresponding air inlet valve (1120 a-1120 n) inan open state for a unique purge time to purge the liquid from channel(1032 a-1032 n). Controller (1124) may perform this process for each ofdevice channels (1032 a-1032 n) independently and simultaneously, suchthat filling and purging of channels (1032 a-1032 n) is performedasynchronously in manner similar to that described above in connectionwith reprocessing system (1000). Accordingly, it will be appreciatedthat reprocessing system (1100) offers at least some of the sameadvantages as system (1000).

VII. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

A method for reprocessing an internal channel of a medical device with areprocessing system having a valve, a fluid line fluidly coupled withthe valve, and at least one sensor coupled with the fluid line, themethod comprising: (a) performing an actuation of the valve to directliquid through the fluid line and into the internal channel; (b) whiledirecting the liquid into the internal channel, detecting with the atleast one sensor a predetermined condition within the fluid line; (c) inresponse to detecting the predetermined condition, recording a timeduration measured from the actuation of the valve; (d) purging theliquid from the internal channel; and (e) directing liquid through thefluid line and into the internal channel for the time duration.

Example 2

The method of Example 1, wherein the predetermined condition within thefluid line comprises at least one of a flow rate of the liquid withinthe fluid line or a pressure within the fluid line.

Example 3

The method of any of the preceding Examples, wherein the at least onesensor comprises a flow rate sensor, wherein the predetermined conditionwithin the fluid line comprises a flow rate of the liquid within thefluid line.

Example 4

The method of any of Examples 1 through 2, wherein the at least onesensor comprises a pressure sensor, wherein the predetermined conditionwithin the fluid line comprises a pressure within the fluid line.

Example 5

The method of any of the preceding Examples, wherein detecting thepredetermined condition within the fluid line comprises detecting thatat least one of a flow rate of the liquid within the fluid line or apressure within the fluid line has reached a steady state.

Example 6

The method of any of the preceding Examples, wherein purging the liquidfrom the internal channel comprises purging the liquid for the timeduration.

Example 7

The method of any of the preceding Examples, wherein purging the liquidfrom the internal channel comprises directing one of a second liquid orpressurized air through the fluid line and into the internal channel.

Example 8

The method of any of the preceding Examples, wherein the actuation ofthe valve comprises a first actuation, wherein the predeterminedcondition comprises a first predetermined condition, wherein the timeduration comprises a first time duration, wherein purging the liquidfrom the internal channel comprises performing a second actuation of thevalve to direct compressed air through the fluid line and to theinternal channel, wherein the method further comprises: (a) whiledirecting compressed air to the internal channel, detecting with the atleast one sensor a second predetermined condition within the fluid line;(b) in response to detecting the second predetermined condition withinthe fluid line, recording a second time duration measured from thesecond actuation of the valve; and (c) after directing liquid throughthe fluid line and into the internal channel for the first timeduration, directing compressed air through the fluid line and to theinternal channel for the second time duration to purge the liquid fromthe internal channel.

Example 9

The method of Example 8, wherein the first predetermined conditionwithin the fluid line comprises one of a flow rate of the liquid withinthe fluid line or a pressure within the fluid line, wherein the secondpredetermined condition within the fluid line comprises one of a flowrate of the liquid within the fluid line or a pressure within the fluidline.

Example 10

The method of any of Examples 8 through 9, wherein the firstpredetermined condition within the fluid line comprises one of a flowrate of the liquid within the fluid line or a pressure within the fluidline, wherein the second predetermined condition within the fluid linecomprises the other of a flow rate of the liquid within the fluid lineor a pressure within the fluid line.

Example 11

The method of any of Examples 8 through 9, wherein detecting the firstpredetermined condition within the fluid line comprises detecting that aflow rate of the liquid within the fluid line has reached a steady stateafter decreasing, wherein detecting the second predetermined conditionwithin the fluid line comprises detecting that a flow rate of the liquidwithin the fluid line has decreased after the second actuation of thevalve.

Example 12

The method of any of Examples 8 through 9, wherein detecting the firstpredetermined condition within the fluid line comprises detecting that apressure within the fluid line has reached a steady state afterincreasing, wherein detecting the second predetermined condition withinthe fluid line comprises detecting that a pressure within the fluid linehas reached a steady state after decreasing.

Example 13

The method of any Examples 8 through 10, wherein detecting the firstpredetermined condition within the fluid line comprises detecting that aflow rate of the liquid within the fluid line has reached a steady stateafter decreasing, wherein detecting the second predetermined conditionwithin the fluid line comprises detecting that a pressure within thefluid line has reached a steady state after decreasing.

Example 14

The method of any of Examples 8 through 10 and 13, wherein the at leastone sensor comprises a flow rate sensor and a pressure sensor, whereinthe flow rate sensor is operable to detect one of the firstpredetermined condition or the second predetermined condition within thefluid line, wherein the pressure sensor is operable to detect the otherof the first predetermined condition or the second predeterminedcondition within the fluid line.

Example 15

The method of Example 14, wherein detecting the first predeterminedcondition within the fluid line comprises measuring with the flow ratesensor a flow rate of the liquid within the fluid line, whereindetecting the second predetermined condition within the fluid linecomprises measuring with the pressure sensor a pressure within the fluidline.

Example 16

A method for reprocessing first and second internal channels of amedical device with a reprocessing system having a first valve, a secondvalve, a first sensor, and a second sensor, the method comprising: (a)performing a first actuation of the first valve to direct fluid into thefirst internal channel; (b) while directing fluid into the firstinternal channel, detecting with the first sensor a first predeterminedcondition associated with the fluid; (c) in response to detecting thefirst predetermined condition, recording a first time duration measuredfrom the first actuation of the first valve; (d) after detecting thefirst predetermined condition, purging the fluid from the first internalchannel; (e) after purging the fluid from the first internal channel,performing a subsequent actuation of the first valve to direct fluidinto the first internal channel for the first time duration; (f) whilecompleting step (a), performing a first actuation of the second valve todirect fluid into the second internal channel while directing fluid intothe first internal channel; (g) while directing fluid into the secondinternal channel, detecting with the second sensor a secondpredetermined condition associated with the fluid; (h) in response todetecting the second predetermined condition, recording a second timeduration measured from the first actuation of the second valve; (i)after detecting the second predetermined condition, purging the fluidfrom the second internal channel; and (j) after purging the fluid fromthe second internal channel, performing a subsequent actuation of thesecond valve to direct fluid into the second internal channel for thesecond time duration.

Example 17

The method of Example 16, wherein the first time duration is differentthan the second time duration.

Example 18

The method of any of Examples 16 through 17, wherein the firstpredetermined condition comprises one of a flow rate or a pressureexerted by the fluid being directed into the first internal channel,wherein the second predetermined condition comprises one of a flow rateor a pressure exerted by the fluid being directed into the secondinternal channel.

Example 19

A method for reprocessing first and second internal channels of amedical device with a reprocessing system having a first pump, a secondpump, a first valve unit, and a second valve unit, the methodcomprising: (a) activating the first pump to direct a first fluid to:(i) a first inlet of the first valve unit, wherein an outlet of thefirst valve unit is in fluid communication with the first internalchannel, and (ii) a first inlet of the second valve unit, wherein anoutlet of the second valve unit is in fluid communication with thesecond internal channel; (b) activating the second pump to direct asecond fluid to: (i) a second inlet of the first valve unit, and (ii) asecond inlet of the second valve unit; and (c) controlling the firstvalve unit independently of the second valve unit such that: (i) thefirst valve unit delivers the first fluid to the first internal channelfor a first time duration and subsequently delivers the second fluid tothe first channel for a second time duration, and (ii) the second valveunit delivers the first fluid to the second internal channel for a thirdtime duration and subsequently delivers the second fluid to the secondchannel for a fourth time duration.

Example 20

The method of Example 19, wherein the first internal channel has a firstinternal diameter and the second internal channel has a second internaldiameter different than the first internal diameter, wherein the firsttime duration is different than the third time duration, whereincontrolling the first and second valve units independently comprisescontrolling the first and second valve units such that the third timeduration overlaps a portion of the first time duration.

VIII. Miscellaneous

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

I claim:
 1. A method for reprocessing first and second internal channelsof a medical device with a reprocessing system having a first valve, asecond valve, a first sensor, and a second sensor, the methodcomprising: (a) performing a first actuation of the first valve todirect fluid into the first internal channel; (b) while directing fluidinto the first internal channel, detecting with the first sensor a firstpredetermined condition associated with the fluid; (c) in response todetecting the first predetermined condition, recording a first timeduration measured from the first actuation of the first valve; (d) afterdetecting the first predetermined condition, purging the fluid from thefirst internal channel; (e) after purging the fluid from the firstinternal channel, performing a subsequent actuation of the first valveto direct fluid into the first internal channel for the first timeduration; (f) while completing step (a), performing a first actuation ofthe second valve to direct fluid into the second internal channel whiledirecting fluid into the first internal channel; (g) while directingfluid into the second internal channel, detecting with the second sensora second predetermined condition associated with the fluid; (h) inresponse to detecting the second predetermined condition, recording asecond time duration measured from the first actuation of the secondvalve; (i) after detecting the second predetermined condition, purgingthe fluid from the second internal channel; and (j) after purging thefluid from the second internal channel, performing a subsequentactuation of the second valve to direct fluid into the second internalchannel for the second time duration.
 2. The method of claim 1, whereinthe first time duration is different than the second time duration. 3.The method of claim 1, wherein the first predetermined conditioncomprises one of a flow rate or a pressure exerted by the fluid beingdirected into the first internal channel, wherein the secondpredetermined condition comprises one of a flow rate or a pressureexerted by the fluid being directed into the second internal channel. 4.The method of claim 1, further comprising (a) after detecting the firstpredetermined condition, holding the fluid in the first internal channelfor a first minimum dwell time, and (b) after detecting the secondpredetermined condition, holding the fluid in the second internalchannel for a second minimum dwell time.
 5. The method of claim 1,wherein the first sensor comprises a flow rate sensor, and wherein thefirst predetermined condition comprises a flow rate of the fluid beingdirected into the first internal channel.
 6. The method of claim 1,wherein the first sensor comprises a pressure sensor, and wherein thefirst predetermined condition comprises a pressure exerted by the fluidbeing directed into the first internal channel.
 7. The method of claim1, wherein the second sensor comprises a flow rate sensor, and whereinthe second predetermined condition comprises a flow rate of the fluidbeing directed into the second internal channel.
 8. The method of claim1, wherein the second sensor comprises a pressure sensor, and whereinthe second predetermined condition comprises a pressure exerted by thefluid being directed into the second channel.
 9. The method of claim 1,wherein detecting the first predetermined condition comprises detectingthat at least one of a flow rate of the fluid or a pressure of the fluidhas reached a steady state.
 10. The method of claim 1, wherein detectingthe second predetermined condition comprises detecting that at least oneof a flow rate of the fluid or a pressure of the fluid has reached asteady state.
 11. The method of claim 1, wherein purging the fluid froma select one or both of the first internal channel and the secondinternal channel comprises directing one of a second fluid orpressurized air through the respective internal channel.
 12. The methodof claim 1, wherein purging the fluid from a select one or both of thefirst internal channel and the second internal channel comprises purgingthe fluid for the first time duration in the case of the first internalchannel, or purging the fluid for the second time duration in the caseof the second internal channel.
 13. The method of claim 1, wherein thefirst predetermined condition comprises one of a flow rate of the fluidor a pressure of the fluid, wherein the second predetermined conditioncomprises the other of a flow rate of the fluid or a pressure of thefluid.
 14. The method of claim 1, wherein detecting the firstpredetermined condition comprises detecting that a flow rate of thefluid has reached a steady state after decreasing, wherein detecting thesecond predetermined condition comprises detecting that a flow rate ofthe fluid has decreased after the subsequent actuation of the valve. 15.The method of claim 1, wherein detecting the first predeterminedcondition comprises detecting that a pressure of the fluid has reached asteady state after increasing, wherein detecting the secondpredetermined condition comprises detecting that a pressure of the fluidhas reached a steady state after decreasing.
 16. The method of claim 1,wherein detecting the first predetermined condition comprises detectingthat a flow rate of the fluid has reached a steady state afterdecreasing, wherein detecting the second predetermined conditioncomprises detecting that a pressure of the fluid has reached a steadystate after decreasing.
 17. The method of claim 1, wherein the fluidcomprises a detergent or a disinfectant.
 18. The method of claim 1,wherein the method steps are repeated for a predetermined number ofcycles.